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Job DescriptionPosition Description: Dr. Praegers was founded in 1994 with the mission to bring delicious frozen food to everyone. Its not every day that two heart surgeons get into the food business, but over 20 years ago thats exactly what our dads did. Motivated by what they saw in their practice, our parents set out on a mission to encourage sensible eating. They knew ingredients had to be nutritious and simple, that everything had to be delicious, and that their products needed to be super simple to make. While the world has changed since our little family business first got started, our focus remains true to our dads vision, and we work every day to make them proud. To learn more visit: Dr. Praeger's HistoryResponsibilities: \tResponsible for compliance with all GMPs, Food Safety procedures, and regulatory standards that are established by OSHA, FDA, USDA, and Dr. Praegers Sensible Foods. \tKeep the work area clean. \tResponsible for keeping pallets neat and orderly. \tTransport trash and debris away from production areas. \tMonitor the efficiency of the production line to ensure timely load and shipment. \tAssemble and prepare goods for shipment. \tAbility to follow directions. \tOperate heavy-duty equipment. \tUtilization of Redzone software \tFill out all documentation completely. \tSupport Machine operators as needed. \tStart and stop equipment. Physical requirements: \tAbility to lift and carry at least 50 lbs. \tMust be able to stand/walk for extended periods of time and frequently push, pull, bend, and reach. Skills (required): \tStrong communication skills. \tAbility to work in a team environment. \tBilingual preferred. Disclaimer: Employee must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodation will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship. Dr. Praeger's Sensible Foods is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, disability, or handicap, sex, marital status, veteran status, sexual orientation, genetic information, arrest record, or any other characteristic protected by applicable federal, state or local laws. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, and general treatment during employment. $16.00 - $16.00 Hourly

Job DescriptionPosition Description: Dr. Praegers was founded in 1992 with the mission to bring delicious frozen food to everyone. Its not every day that two heart surgeons get into the food business, but over 20 years ago thats exactly what our dads did. Motivated by what they saw in their practice, our parents set out on a mission to encourage sensible eating. They knew ingredients had to be nutritious and simple, that everything had to be delicious, and that their products needed to be super simple to make. While the world has changed since our little family business first got started, our focus remains true to our dads vision, and we work every day to make them proud. To learn more visit: Dr. Praeger's HistoryResponsibilities: \tResponsible for compliance with all GMPs, Food Safety procedures, and regulatory standards that are established by OSHA, FDA, USDA, and Dr. Praegers Sensible Foods. \tKeep the work area clean. \tResponsible for keeping pallets neat and orderly. \tTransport trash and debris away from production areas. \tMonitor the efficiency of the production line to ensure timely load and shipment. \tAssemble and prepare goods for shipment. \tAbility to follow directions. \tOperate heavy-duty equipment. \tUtilization of Redzone software \tFill out all documentation completely. \tSupport Machine operators as needed. \tStart and stop equipment. Physical requirements: \tAbility to lift and carry at least 50 lbs. \tMust be able to stand/walk for extended periods of time and frequently push, pull, bend, and reach. Skills (required): \tStrong communication skills. \tAbility to work in a team environment. \tBilingual preferred. Disclaimer: Employee must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodation will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship. Dr. Praeger's Sensible Foods is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, disability, or handicap, sex, marital status, veteran status, sexual orientation, genetic information, arrest record, or any other characteristic protected by applicable federal, state or local laws. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, and general treatment during employment. $16.00 - $16.00 Hourly

Job Description Division │ Department: PharmaLogic Position Title: Theranostics Manufacturing Associate Reports To: Theranostics Laboratory Manager Role Summary: Join our team at the forefront of precision medicine. As a Theranostics Manufacturing Associate, you’ll be part of a team bringing innovative radiopharmaceutical treatments from the lab to patients who need them most. You’ll gain hands-on experience in producing and validating cutting-edge life-changing therapies. This hands-on position involves radiochemistry synthesis, aseptic processing, and quality control — ensuring every dose meets the highest standards of safety and innovation, in a collaborative, purpose-driven environment. Job Responsibilities and Duties: 1. Responsible for production of radiopharmaceuticals: • Synthesis of diagnostic and therapeutic radiopharmaceuticals., • Analytical testing using HPLC, GC, TLC and other techniques., • Aseptic processing and fill/finish operations., • Completion of associated cGMP documentation. 2. Operate and maintain automated radiochemistry synthesis units., 3. Operate and maintain onsite analytical equipment., 4. Assist with improvement of current cGMP and non-GMP processes., 5. Follow all SOP guidelines for manufacturing and QC release testing of radiopharmaceutical product, raw material, finished and semi-finished product, environment and facilities., 6. Maintain clean and safe work environment, performing radiation safety duties in compliance with safety and pharmaceutical regulations., 7. Maintain accurate production and test/validation results., 8. A passion for continuous learning and curiosity to find innovative ways to improve our ways of working., 9. Perform other job-related duties as assigned. Job Requirements │ Skills │ Education: • Requires a bachelor's degree in chemistry or related field. · Two or more years of laboratory experience are preferred. • Familiarity with a GMP manufacturing environment and working with FDA and FDA cGMP regulations required. Knowledge of molecular imaging techniques and pharmaceutical study design and execution desired., • Experience with laboratory procedures and analytical equipment (HPLC, GC, TLC, ICP, Radiation measurement) strongly preferred., • Experience with radiation protection techniques and laboratory safety strongly preferred. • Superior teamwork, multi-tasking and time/project management skills., • Excellent communication, analytical, problem solving, presentation and computer/pc skills (including proficiency in Microsoft Suit and related software). · Superior attention to detail in a fast-paced and dynamic environment. Ability to work varying shifts both independently and as part of a team. Physical and Intellectual Requirements: Required are a mechanical aptitude; manual dexterity for manipulating small items; ability to lift between 16 to 50 lbs. and to handle frequent crawling, stooping, crouching and kneeling; ability to analyze situations, set priorities and meet deadlines.

Job DescriptionLexeo is building the future of cardiac genetic medicine, and we’re looking for a bold, strategic leader to help us get there. As a Senior Director or Vice President, GxP Quality, you will lead the charge in scaling our Quality organization across clinical and commercial manufacturing programs, embedding excellence into every step of our journey from development to commercial launch. You’ll architect a globally compliant, phase-appropriate GxP strategy that empowers innovation while ensuring rigor. You’ll shape systems, guide teams, and drive decisions that keep science at the center and quality at the forefront. This is your opportunity to lead with purpose, influence across functions, and build a culture where accountability, collaboration, and continuous improvement thrive. If you’re energized by challenges, inspired by impact, and ready to help set a new standard in genetic medicine, this is your moment. Lexeo is seeking an experienced and hands-on senior leader of GxP Quality to be accountable for both leading and operationalizing strategy to scale our Quality organization across clinical development, manufacturing, translational sciences and clinical biomarkers . This individual will be responsible for developing a phase-appropriate, scalable GxP Quality strategy, ensuring compliance with global regulatory standards (e.g., FDA, EMA, ANVISA, ICH), and embedding a culture of operational excellence across the company. The ideal candidate will bring deep GMP and GCP expertise, strong leadership and communication skills, and the ability to thrive in a fast-paced, development-stage environment while providing strategic oversight and pragmatic solutions that enable innovation. Key Responsibilities * Quality Leadership & Strategy • Develop and execute a scalable GxP Quality Assurance strategy aligned with Lexeo’s business goals and regulatory expectations., • Serve as the senior Quality leader across GMP, GCP, GLP, and GVP functions., • Advise executive leadership on quality risks, mitigation strategies, and inspection readiness., • Foster a proactive quality culture rooted in continuous improvement, accountability, and operational excellence., • Establish and maintain a phase-appropriate Quality Management System (QMS) establishing a document hierarchy including a Quality Manual, policies, SOPs and other documents needed to support a virtual gene therapy organization with early and late stage programs. And, also enabling a QMS that can support a registrational study and commercial launch., • Ensure quality systems effectively support clinical development, pharmacovigilance, all CMC activities, translational sciences, clinical biomarker development, and external partnerships, • Lead and/or provide leadership support for GCP, GLP, GMP and GVP quality activities, including internal and external audits, vendor oversight, deviation investigations, and quality agreements, health authority inspections., • Support clinical trial operations by ensuring all aspects of ICH GCP are followed (e.g., protocol adherence, data integrity, and informed consent compliance), • Oversee early and late phase manufacturing QA activities, including batch record review, product release, and disposition in collaboration with CMC and Technical Operations, • Drive inspection readiness and represent Lexeo during regulatory inspections and partner audits, • Oversee and management of a risk-based vendor qualification program including performance of external audits, and ongoing compliance monitoring of CROs, CDMOs, testing laboratories, and other GxP service providers, • Partner closely with Clinical Development, Regulatory Affairs, Technical Operations, Supply Chain, and Research to ensure quality is embedded throughout the product lifecycle, • Serve as the QA representative on governance bodies and cross-functional development teams, ensuring risk-based decision-making and clear communication of quality principles Qualifications, • Bachelor’s degree in a relevant scientific discipline (Biology, Chemistry, Engineering, or related field); advanced degree preferred, • 12–15+ years of experience in Quality Assurance within the biotech or pharmaceutical industry, with significant exposure to both GMP and GCP environments, • Proven leadership in building and scaling GxP quality systems within a clinical- to commercial-stage setting, • Strong knowledge of FDA, EMA, and ICH regulations and inspection practices, • Experience in regulatory submissions, from IND to BLA, in support of CMC and clinical components, • Experience managing audits, CAPAs, deviations, and regulatory inspections, • Demonstrated success leading external partnerships (CROs, CDMOs), • Excellent communication, collaboration, and problem-solving skills with the ability to influence across functions and levels, • Strategic thinker who can balance regulatory rigor with Lexeo’s innovative, fast-paced biotech environment Preferred Experience, • Experience with AAV-based gene therapy or biologics, • Familiarity with global clinical trial operations and pharmacovigilance practices

Job DescriptionAbout Amigo Amigo builds AI agents for healthcare—systems that handle patient conversations, take clinical actions, and escalate to humans when needed. Clinical research focuses on healthcare-specific problems: evaluation frameworks for clinical safety, methods for learning what works across patient populations, and ensuring agent behavior meets the standards healthcare organizations require. Series A from leading investors. Clinical validation and evidence generation in partnership with leading academic medical institutions. About this role As a Clinical Research Scientist at Amigo, you'll lead research on clinical AI safety, evaluation frameworks, and evidence generation. You'll design studies that validate agent performance across patient populations, develop metrics for clinical quality, and publish findings that advance the field. Your clinical expertise ensures our agents meet the standards required for autonomous operation in healthcare. This role bridges clinical practice and AI research. You'll work directly with our agent engineering and data science teams to translate clinical knowledge into measurable evaluation criteria and safety guardrails. What you'll do * Design and lead clinical validation studies for AI agent performance * Develop evaluation frameworks and metrics for clinical safety and quality * Publish research on clinical AI safety and agent evaluation methodologies * Collaborate with academic medical institutions on research partnerships * Define clinical protocols and escalation criteria for agent behavior * Review agent outputs and failure modes from a clinical perspective * Contribute to regulatory submissions and compliance documentation * Advise on clinical workflow design and patient safety considerations What we're looking for * MD or equivalent medical degree with active clinical license * Clinical experience in primary care, internal medicine, or relevant specialty * Track record of clinical research and peer-reviewed publications * Understanding of clinical quality metrics and patient safety frameworks * Experience with clinical study design and IRB processes * Ability to translate clinical expertise into technical requirements * Strong communication across clinical, research, and engineering teams * Interest in AI/ML applications in healthcare Nice to have * Fellowship or additional training in clinical informatics * Experience with digital health or health technology companies * Background in quality improvement or patient safety initiatives * Familiarity with FDA guidance on clinical decision support and AI/ML * Experience with EHR systems and clinical workflow optimization * Publications in clinical AI, digital health, or health informatics Benefits Health & Wellness * Comprehensive health, dental, and vision insurance * Mental health support and wellness coaching * Flexible wellness stipend for fitness, therapy, or personal growth * Daily catered lunch and dinner Growth & Development * Annual learning budget for courses, books, or conferences * Conference attendance budget for professional development * Development setup of your choice * Academic collaboration opportunities Compensation Range: $150K - $300K

Job Description Who we are: For over 20 years, Global Relay has set the standard in enterprise information archiving with industry-leading cloud archiving, surveillance, eDiscovery, and analytics solutions. We securely capture and preserve the communications data of the world's most highly regulated firms, giving them greater visibility and control over their information and ensuring compliance with stringent regulations. Though we offer competitive compensation and benefits and all the other perks one would expect from an established company, we are not your typical technology company. Global Relay is a career-building company. A place for big ideas. New challenges. Groundbreaking innovation. It's a place where you can genuinely make an impact – and be recognized for it. We believe great businesses thrive on diversity, inclusion, and the contributions of all employees. To that end, we recruit candidates from different backgrounds and foster a work environment that encourages employees to collaborate and learn from each other, completely free of barriers. Your role: Join Global Relay, a leading provider of compliance software solutions, as we embark on an exciting journey to expand our footprint in the healthcare and life sciences industry. We're seeking a seasoned Senior Account Executive to drive sales growth and establish strong relationships with key decision-makers in this critical sector. Our cutting-edge compliance software solutions are designed to help healthcare organizations and life sciences companies maintain regulatory compliance, ensure data security, and optimize legal and compliance operations. With a strong focus on archiving and surveillance needs, our solutions address the complex challenges of HIPAA, FDA regulations, and other industry-specific requirements. As a Senior Account Executive, you will play a critical role in identifying and addressing the unique needs of these organizations, demonstrating the value of our solutions, and guiding them through the sales process. The ideal candidate will have a proven track record in software sales, specifically in compliance-related solutions, and a strong understanding of the regulatory landscape within healthcare and life sciences. You will work closely with prospects to identify their unique needs, demonstrate the value of our solutions, and guide them through the sales process from initial engagement to closing. Your responsibilities: • Sales & Business Development:, • Prospect, identify, and target new business opportunities in the healthcare and life sciences verticals with a focus on compliance-related archiving and surveillance solutions., • Develop and execute strategic sales plans to meet or exceed annual revenue targets., • Lead the full sales cycle, including prospecting, needs assessment, product demonstrations, proposal development, negotiations, and closing deals., • Consultative Selling & Solution Design:, • Conduct in-depth needs assessments with prospective clients to understand their challenges related to data archiving, eDiscovery, surveillance, and regulatory compliance., • Provide expert consultation on how our software solutions can address their specific compliance requirements, streamline workflows, and mitigate risk., • Build and maintain strong, long-term relationships with key decision-makers at healthcare organizations and life sciences companies., • Industry Knowledge & Regulatory Expertise:, • Stay informed about the latest industry trends, regulations, and compliance standards (e.g., HIPAA, FDA regulations, 21 CFR Part 11, GxP, GDPR, DOJ) affecting the healthcare and life sciences sectors., • Use your knowledge of the healthcare and life sciences industries to clearly articulate the benefits and value of compliance-focused archiving and surveillance solutions., • Collaboration & Reporting:, • Collaborate with cross-functional teams, including marketing, customer success, and revenue operations, to align on sales strategies and customer needs., • Provide regular updates on sales progress, pipeline status, customer feedback, and market trends to management., • 7-10+ years of experience in sales, with a strong focus on compliance software solutions, preferably in the healthcare and life sciences industries., • Experience with archiving, surveillance, or compliance-related software solutions is preferred., • Exceptional consultative selling skills, with the ability to understand complex customer requirements and translate them into tailored software solutions., • Strong understanding of regulatory compliance and guidance in the healthcare and life sciences sectors (e.g., HIPAA, FDA, 21 CFR Part 11, DOJ ECCP)., • Bachelor's degree in Business, Life Sciences, Healthcare Administration, Computer Science, Risk Management, or a related field., • Knowledge of Salesforce, Zoom Info, LinkedIn Sales Navigator, and Demandbase are preferred., • Strong communication, presentation, and negotiation skills., • Ability to build relationships with C-level executives, IT professionals, Legal, and Compliance officers., • Self-starter with a goal-oriented mindset and the ability to thrive in a fast-paced, target-driven environment. Compensation: Global Relay advertises the pay range for this role in compliance with applicable pay transparency laws. Individual pay rates are determined by evaluating factors such as expertise, skills, education, and professional background. The range below reflects the expected annual base salary, which is only one element of our comprehensive total rewards package designed to reflect our company pay philosophy, culture and values. We aim to foster an inspiring work environment and support employees' work-life rhythms. We provide a comprehensive health benefits program, including extended health coverage, and short-term / long-term disability insurance. Employees receive annual allotted vacation days, which increase based on tenure. Other benefits include paid sick days, maternity/parental leave enhanced program, commuter benefits, and a 401(k)-retirement plan with company contribution matching. This role is also eligible for a commission structure. For employees at our New York office, we provide additional perks and amenities to enhance your work experience including a subsidized meal program, courtesy of our in-house culinary team! Base salary$150,000—$200,000 USD What you can expect: At Global Relay, there's no ceiling to what you can achieve. It's the land of opportunity for the energetic, the intelligent, the driven. You'll receive the mentoring, coaching, and support you need to reach your career goals. You'll be part of a culture that breeds creativity and rewards perseverance and hard work. And you'll be working alongside smart, talented individuals from diverse backgrounds, with complementary knowledge and skills. Global Relay is an equal-opportunity employer committed to diversity, equity, and inclusion. We seek to ensure reasonable adjustments, accommodations, and personal time are tailored to meet the unique needs of every individual. To learn more about our business, culture, and community involvement, visit .

Job DescriptionCompany Description Come join a growing team! FOODMatch is searching for a QA & Sustainability Coordinator to join our Quality Assurance team. FOODMatch is a producer and importer of Mediterranean specialty foods with a focus on olives, antipasti, and ingredients. Founded in 1996, FOODMatch is a producer and importer of Mediterranean specialty foods with a distinct expertise in traditionally and responsibly crafted olives, antipasti, spreads, sauces, and ingredients. FOODMatch plays an integral role in ensuring the quality of our products. The FOODMatch difference begins in the fields and groves. We are vertically integrated with our partners to ensure that each step along the production chain is completed to meticulous standards: from irrigation and pruning, to harvesting, sorting and stuffing by hand, to expertly curing and preserving, we ensure each ingredient delivers its natural flavor, color, and texture. Simply put, no detail is spared. Through the hands of our growers we create great tasting, responsibly produced, authentic foods that nurture community and enhance your quality of life. Job Description The QA & Sustainability Supervisor plays a key role in ensuring FOODMatch products meet the highest standards of quality, safety, and compliance while driving forward the company’s sustainability goals. This position oversees product specification management, supplier compliance, and sustainability initiatives across the supply chain. The QA & Sustainability Supervisor serves as a cross-functional link between Quality Assurance, Operations, Procurement, and Marketing teams to uphold regulatory, environmental, and ethical standards. Essential Functions Quality Assurance Oversight • Ensure timely completion of product reviews, labeling, and documentation, • Oversee product specification maintenance, ensuring all products are accurately documented and compliant with FDA and customer requirements., • Partner with suppliers and internal departments to review and approve new product documentation, labels, and certifications., • Review testing and analytical data to confirm products are within specification and meet FOODMatch quality standards., • Support root cause analysis and corrective actions related to product quality concerns., • Ensure ongoing compliance with FDA, FSMA, HACCP, and third-party certification requirements., • Manage and maintain customer portals and documentation systems to ensure all certifications and specifications are current., • Develop, implement, and monitor sustainability initiative projects aligned with FOODMatch’s environmental and social responsibility goals., • Collaborate with Procurement and Supply Chain teams to assess supplier sustainability practices and maintain sustainability-related certifications (e.g., Non-GMO, organic, fair trade)., • Track and report sustainability metrics, including packaging initiatives, waste reduction, and energy efficiency programs., • Identify opportunities to enhance QA systems, documentation workflows, and sustainability processes., • Lead or participate in cross-departmental projects focused on process optimization and environmental impact reduction., • Provide training and guidance to internal teams and suppliers on QA and sustainability standards.Qualifications Background Requirements • Bachelor’s degree in Food Science, Environmental Science, or a related STEM field preferred., • 3+ years of experience in food quality assurance, compliance, or sustainability roles., • Strong understanding of FDA labeling, food safety regulations, and sustainability best practices., • Strong leadership and project management skills with the ability to manage multiple priorities., • Exceptional attention to detail and organizational skills., • Analytical mindset with a passion for both product quality and environmental impact., • Effective communication and cross-functional collaboration skills., • Proficiency in Microsoft Office and online customer/partner portals., • Genuine enthusiasm for food, sustainability, and continuous improvement. Additional Information Travel Requirements • This role requires moderate travel All your information will be kept confidential according to EEO guidelines. Job Type: Full-time Benefits: • 401(k), • Dental insurance, • Health insurance, • Paid time off, • Travel reimbursement, • Vision insurance

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job overview: The Senior Manager, Clinical Quality is responsible for developing and implementing a risk-based GCP (Good Clinical Practice) audit program. This includes planning and conducting audits, coordinating the activities of independent QA auditors, and supporting regulatory inspection readiness activities and regulatory inspections by EMA, FDA and other competent authorities. The role contributes to quality risk management and continuous improvement across clinical trials and related processes. Location: Remote on the East Coast, USA or hybrid working in our NYC office. Reports to: Director, Clinical Quality. Responsibilities (include but are not limited to): • Provision of GCP QA advice and support to clinical project teams and cross-functional departments to help ensure compliance with applicable regulations and internal quality standards, • May act on behalf of the Director, Clinical QA, to provide leadership support and ensure continuity of QA oversight and decision-making, • Manage GCP audits of sites, documents, databases, vendors, or internal systems in compliance with GCP and Compass quality standards, • Coordinate activities of external auditors, during the preparation, conduct and reporting of GCP audits, • Support, and conduct when required, risk-based audits of clinical trial sites, both internally and those managed by CROs (Contract Research Organizations), vendors and internal systems ensuring adherence to GCP guidelines, protocols, and regulatory standards, • Support the preparation of comprehensive audit reports, identifying potential issues and recommending corrective actions for internal teams and collaborating with CROs to implement necessary changes, • Work closely with internal teams to ensure alignment with GCP expectations to address findings and action items from audits, • When required, lead investigations into significant quality issues, facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness, • Proactively assess compliance issues and risks; serve as the expert GCP consultant for issue management & issue escalation, • Support partner organizations as necessary to ensure that timelines are met, milestones and products are delivered on schedule, and any excursions, deviations, investigations, and CAPAs are initiated, addressed, and closed within target timeframes, • Support the management of GCP inspections within Compass and at vendors/partners of Compass studies and/or processes, as required, • Liaise with regulatory agencies (e.g., FDA, EMA) regarding GCP compliance matters, • Stay up-to-date on evolving GCP regulations and best practices in clinical trial audit methodology, • Participate in the development and implementation of training programs for clinical trial staff, both internal and at CRO partners, on GCP and regulatory compliance, • Degree in a life science field or a related clinical research area (preferred), • GCP QA professional with broad drug experience which spans all clinical phases (Phase I to IV), • Extensive experience in GCP auditing and clinical trial operations, • In-depth knowledge of GCP guidelines (ICH-GCP) and regulatory requirements for clinical trials, • Strong understanding of clinical trial design, conduct, and data management, • Excellent leadership, communication, and interpersonal skills, • Strong analytical and problem-solving skills, • Ability to work independently and as part of a team, • Excellent project management skills Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Job Description About the Role: The Quality Manager supports the food safety and quality assurance function by managing day-to-day quality operations in a food manufacturing facility. This role ensures production processes, products, and documentation meet regulatory, customer, and certification requirements. The Quality Manager supervises inspection and testing activities, leads the quality team on the plant floor, and supports audit readiness, reporting directly to senior FSQA leadership. PCQI certification is required for this position. Responsibilities: * Supervise daily quality control and inspection activities, including raw material verification, in-process checks, and finished product release. * Serve as site PCQI, supporting Preventive Controls for Human Food programs in compliance with FSMA requirements. * Maintain and update quality documentation including SOPs, HACCP records, and batch production records. * Monitor sanitation verification, allergen control, environmental monitoring, and traceability procedures. * Ensure compliance with FDA, USDA, HACCP, GMP, and customer quality standards. * Lead, train, and coach quality technicians and inspectors to uphold consistent quality practices. * Support FSQA leadership during third-party, regulatory, and customer audits by maintaining audit readiness and documentation. * Track and report quality metrics, investigate deviations, and implement corrective and preventive actions. * Collaborate with operations, R&D, and supply chain teams to address quality concerns and improve processes. * Promote a culture of food safety, quality, and continuous improvement across the production floor. Qualifications: * Bachelors degree in Food Science, Microbiology, Chemistry, or a related field. * PCQI certification required, with demonstrated application in food manufacturing. * 3-5 years of quality assurance or food safety experience in food or beverage manufacturing. * Knowledge of FSMA, HACCP, GMP, and FDA/USDA regulatory requirements. * Strong experience supervising quality technicians and overseeing plant-floor quality operations. * Proficiency with root cause analysis, corrective actions, and quality improvement methods. * Strong communication and organizational skills, with attention to detail. Desired Qualifications: * HACCP or SQF Practitioner certification. * Experience with environmental monitoring, sanitation verification, and allergen management programs. * Familiarity with ERP or QMS systems for quality tracking and documentation. * Training in Lean Manufacturing, Six Sigma, or continuous improvement methodologies. * Ability to adapt to fast-paced production environments and support cross-functional teams.

Job DescriptionPosition Title: I.P. - Technology Transactions (Life Sciences) Associate Location: Silicon Valley, Boston, New York, San Francisco, Santa Monica, Seattle, Washington, D.C. Salary Range: $235,000 - $310,000 About the Opportunity • We are currently seeking associates with two (2) to four (4) years of licensing / collaboration and commercial partnering transactions experience for our growing life sciences technology transactions practice., • The ideal candidate will have substantial law firm experience representing biotechs and big pharmas as they license patents and collaborate to advance novel therapeutics, vaccines, diagnostic and digital health technologies through clinical trials and toward regulatory (FDA) approval., • Experience working with AI-native or AI-driven biotechnology companies—particularly those integrating artificial intelligence or machine learning into drug discovery, diagnostics, or life sciences R&D—is a plus., • This is an ideal position for candidates seeking to work closely with founders developing cutting edge technologies and negotiate complex standalone commercial transactions that transform both the technologies and participants. The position also suits those desiring both life sciences and broader tech exposure., • Superior academic credentials, excellent oral, written and interpersonal skills required. Items Needed to Apply: Resume, Cover Letter, Law School Transcript. Confidentiality For confidentiality reasons, the client’s name is not disclosed at this stage. Qualified candidates will receive full details upon initial screening.

Job DescriptionAs Senior Counsel, Advertising and Promotion, you'll be responsible for reviewing advertising, promotional, and other consumer-facing materials, ensuring they are compliant with FTC and FDA regulations and guidelines, and also manage a junior advertising and promotion attorney. You’ll partner closely with our Growth and Marketing teams to counsel on marketing content across the full spectrum of platforms, including websites, social media, podcasts, billboards, and TV. You have a strong knowledge of FDA and FTC advertising regulations and cases, and particularly with respect to prescription drugs and health products. You're smart, collaborative, and comfortable working in a dynamic environment while handling several projects at the same time. What You'll Do: • Serve as an internal subject matter expert on FTC and FDA advertising and promotion issues as they pertain to health products, and provide guidance to cross-functional teams to maintain compliance with FTC and FDA laws and regulations., • Sit on Ro’s collaborative medical-legal-marketing review process and review the creative assets for regulatory compliance. This content includes: Facebook and Google ads, website pages, national TV spots, podcast reads, billboards, contests and sweepstakes, and more., • Collaborate with cross-functional teams to support new strategic initiatives and advertising campaigns., • Stay abreast of changes in FDA and FTC regulations and industry trends in advertising, and monitor enforcement actions and relevant litigation., • Maintain company-wide guidelines and conduct trainings on advertising and promotion., • Provide guidance and oversight to an advertising and promotion attorney.What You'll Bring:, • Juris Doctor (JD) from an accredited law school., • Active member in good standing of a state bar association., • 5-8 years of experience practicing FDA and FTC law, and extensive expertise in the area of advertising and promotion of FDA-regulated products., • Exceptional analytical, research, and writing skills., • Strong communication and interpersonal skills, with the ability to build relationships across all levels of the organization., • Business-oriented mindset with the ability to translate legal advice into practical solutions., • Adaptable and able to thrive in a fast-paced, dynamic environment., • Self-starter with the ability to manage multiple projects simultaneously and meet deadlines., • Passion for the telehealth industry and a desire to make a meaningful impact.We've Got You Covered:, • Full medical, dental, and vision insurance + OneMedical membership, • Healthcare and Dependent Care FSA, • 401(k) with company match, • Flexible PTO, • Wellbeing + Learning & Growth reimbursements, • Paid parental leave + Fertility benefits, • Pet insurance, • Student loan refinancing, • Virtual resources for mindfulness, counseling, and fitness

Job DescriptionJob Title: REMOTE Territory Sales Manager – Specialty Chemicals & APIsCompensation: $100,000–$130,000 base + performance incentives Location: Remote (U.S.) Industry: Specialty Chemicals / APIs / Pharmaceutical Intermediates Overview A global manufacturer of specialty chemicals and pharmaceutical ingredients is expanding its North American commercial team. This is a high-impact sales role focused on growth within key verticals including iodine derivatives, intermediates for anti-cancer and contrast media, and active pharmaceutical ingredients (APIs). The role is modeled on a proven sales structure used for similar markets, emphasizing relationship management, business development, and strategic positioning across nutraceutical, pharma, and fine chemical sectors. Key Responsibilities * Drive sales growth across the North American territory for specialty and pharmaceutical-grade chemical ingredients. * Identify, target, and close new business opportunities across the following categories: * Iodine derivatives * Anti-cancer drug intermediates * X-ray and contrast media intermediates * APIs and stomach-related APIs * Develop and maintain relationships with key accounts, distributors, and manufacturers. * Collaborate closely with global production and regulatory teams to ensure compliance and delivery. * Analyze market trends and identify high-value prospects for long-term partnerships. * Represent the company at key trade shows and industry events (e.g., IBIE, CPhI, SupplySide West). * Prepare detailed reports and forecasts for executive management. Qualifications * Bachelor’s degree in Chemistry, Chemical Engineering, or related field (advanced degree a plus). * Minimum 5 years of experience in B2B sales of specialty chemicals, APIs, or pharmaceutical intermediates. * Proven track record of achieving revenue goals and building strategic partnerships. * Familiarity with regulated markets (FDA, REACH, GMP) preferred. * Exceptional communication, negotiation, and presentation skills. * Self-motivated, entrepreneurial mindset; able to operate with minimal supervision. Compensation & Benefits * Base salary between $100,000 and $130,000, depending on experience. * Performance-based commission and annual bonus structure. * Health coverage, paid time off, and travel reimbursement. * Long-term growth opportunity with a global chemical leader expanding in the U.S. market.

Job Description Reports to: General Manager With a projected 1,000 cafes in the United States by 2030, Paris Baguette is one of the fastest-growing neighborhood bakery cafés in the world. Our vision is to reestablish the neighborhood bakery café as the heart of the community around the world. Paris Baguette’s mission is to bring expertly crafted baked and brewed goods through a warm and welcoming bakery café experience that delivers joy to everyone. If you are someone who has heart, wants to spread joy, nourish community and is ready to rise to the occasion, we are looking for you to join our growing team! WHAT WE ARE HUNGRY FOR Our certified Bakers are true masters of their crafts. The quality and beauty of their creations are second to none. That level of quality and commitment to excellence is found in everyone who works with us. As a Baker, you will be passionate about baking, quality and creating delicious desserts! Our ideal candidate will help to achieve our mission to bring expertly crafted baked and brewed goods to our guests through a warm and welcoming bakery café experience that delivers joy to everyone. KNOWLEDGE AND RESPONSIBILITIES • Responsible for frying donuts, placing toppings, and decorating on needed pastries and bread, • Carrying out operations and productions that takes place in the kitchen, • Baking recipes and preparing all desserts, • General Oven Duties (Checking dough conditioner), • Preparing all needed materials and ingredients, • Responsible for scaling and shaping of all breads, loaves, and pastries, • Sanitization procedures, maintaining overall cleanliness of work station and kitchen, • General knowledge of production methods and organization of bread production, • Must be able to prioritize and finish all tasks assigned for the daily baking, • Ensuring work place is safe and hygienic for all employees and guests, • Receive, stock, and store food in designated containers and storage areas in an organized manner, • Inform supervisors when equipment is not working properly and manage when food supplies are getting low, • Complete various reports for records such as production, usage, and waste, • Knowledge on food producing process, sanitization, quality program, • Knowledge on food producing technique, food microbiology, and food sanitary safety practice/procedure, • Ability to work weekends and holidays., • Food safety, food labeling, nutrition related knowledge (include FDA), • Confectionery/Foods major recommended, • Food Handler’s Certificate, preferred, • Effective communication skills and ability to work in a team environment, • Ability to multi-task, • Multiple priority management abilities, • Feedback is a gift! We can only learn, grow and improve our service if we hear and understand what it is our customers are telling us., • High emotional intelligence with the ability to work with, and manage diverse teams by being highly empathetic, intuitive, self-motivated and driven., • Teams Win! Has to be a team player who fosters a collaborative and engaged teamwork environment., • Flexible work schedule, • Competitive compensation, • Discounted meals during your shift, • Free Cake for your Birthday, • Medical, Dental and Vision Benefits for full time employees

Job Description Location: This role is onsite at CPMI in Miami, FL If you are not local to Miami, let's discuss how to get you there! This is a newly created role at an amazing, top clinical research site located in Miami, FL About Company: Who is ERG? ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with an expertise in early and late-stage neuroscience drug development. With 19 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 340+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally. About the Role: We are seeking a highly qualified Manager/Director of Clinical Operations, Phase I, to oversee clinical trials, ensuring protocol adherence, and managing both staff and operational aspects of studies. This role demands strict compliance with GCP, ICH guidelines, and company SOPs. Core duties include staff management, protocol review, quality assurance, and overall study supervision. Responsibilities: • Lead and mentor the clinical operations team to promote a collaborative and efficient environment., • Ensure protocol compliance and maintain high-quality standards across studies., • Collaborate closely with Principal Investigators and Site Directors to assign studies and develop enrollment strategies., • Oversee human resources functions, including staff evaluations, recruitment, and training., • Monitor adherence to protocols, reporting any deviations to sponsors and regulatory bodies., • Coordinate with Site Director and Principal Investigator to assign primary clinical research coordinators., • Review study components with Principal Investigators and Site Directors, identifying areas requiring clarification before study initiation., • Conduct study closeout procedures., • Perform additional duties as needed to adapt to the evolving needs of CPMI., • Bachelor's degree in a scientific or healthcare-related field, • 7-10 years of experience in clinical operations, including 5+ years in a senior leadership role., • Strong understanding of FDA, ICH, and GCP regulations and guidelines, • Strong communication, organizational, and leadership skills., • Ability to travel as needed and proficiency in Microsoft Word, Excel, and clinical management software., • In-depth knowledge of clinical trial operations, including study start-up, site selection, patient recruitment, monitoring, data management, and study close-out, • Phase I or early phase experience Our comprehensive benefits package includes: • Health insurance, • Dental & Vision Insurance, • Matching 401k Retirement Plan, • Paid Time Off (PTO)

Job Description Who We Are: Click Therapeutics, Inc., develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. As a leading innovator of Digital Therapeutics™, Click delivers accessible, clinically proven, FDA-regulated prescription treatments to the smartphone in your hand. Click's treatments are defined by a commitment to applying technical and scientific rigor and patient-centric design to the development process. This results in uniquely engaging experiences that achieve compelling clinical outcomes for patients seeking new treatment options. Click Therapeutics continuously expands and refines its platform with novel cognitive, behavioral and neuromodulatory mechanisms of action and advanced data-driven tools such as artificial intelligence and machine learning. The digital therapeutics under development on Click's platform address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases. Consistently named a best place to work, Click fosters an inclusive, diverse workforce of innovators, clinicians, scientists, researchers, designers, technologists, engineers and more, united in a common mission to provide patients everywhere access to safe and effective prescription digital therapeutics. For more information, visit and connect with us on LinkedIn. About the Role: We are looking for a Senior Product Manager who is confident in their ability to understand the needs of the users of our products and transform that understanding into engaging solutions to their problems. Click's software and technology is pioneering in health care which requires the product managers at Click to collaborate with multiple experts such as clinicians, scientists, product designers, software engineers, market researchers and data scientists. The Senior Product Manager will be focused on delivering our pipeline products through clinical trials and to market. This position is based out of Click's headquarters located in Tribeca, NYC, at the center of one of the fastest-growing digital health communities. We have a hybrid working model that consists of at least 3 days in office each week. Responsibilities: • Work in collaboration with scientific, business, and engineering leaders to rapidly define and develop features that deliver therapeutic value to our patients & our partners., • Understand scientific concepts and identify opportunities to translate ideas into testable, scalable products and prototypes., • Deeply understand and synthesize the complexities of the healthcare environment including regulations, existing clinical workflows, and patient journeys into high potential product opportunities., • Facilitate workshops with external business partners to gather requirements, drive consensus, and clarify strategic direction., • Translate requirements into clear user stories that can be efficiently communicated to the development team to deliver into working software., • Work closely with the development team, acting as a key driver for Agile ceremonies such as Stand up, Retrospective, Sprint Planning & Sprint Reviews., • Manage timelines and a product roadmap to organize timely feature releases and minimize release delays., • Drive effective teamwork, communication, collaboration and commitment across multiple departments., • 4+ years of experience working as a Product Owner or Product Manager in an Agile and/or SCRUM environment for mobile products., • Experience in bringing a software product to market, or managing a major release for a live product., • Experience working on cross-functional teams to deliver software applications., • Excellent verbal and written communication skills, demonstrated through the creation of strong presentation materials, product requirements documents & user stories., • Strong facilitation skills, with experience in managing the requests & expectations of multiple stakeholders and upper management., • Strong technical leadership, project management, analytical problem solving, business analysis, and troubleshooting skills., • Experience with systems design and/or foundational coding concepts., • Experience translating technical concepts and solutions to non-technical and executive audiences., • Experience conducting user research through both qualitative and quantitative methods., • Individuals who are fluent in speaking, writing and reading in Japanese are strongly preferred., • Background or previous experience in neuroscience, psychiatry, psychology, behavior change, digital health or a related field., • Experience in consulting or client services., • Experience in Cultural Change/Digital Transformation projects., • Experience conducting clinical research. The base salary range for this position is between: $125,000 - $175,000. The final base salary will be dependent upon skills, experience and location. In addition to the base salary, Click Therapeutics offers an annual performance-based cash bonus and a generous equity package. Benefits: The role includes great benefits and is an excellent wealth-building opportunity at a fast-growing pre-IPO company in a nascent and extremely exciting space. Competitive Salary with Annual Review | Cash Bonus | Stock Options | 5% 401(k) matching | Medical | Dental | Vision | Life Insurance | Voluntary Benefits | Unlimited PTO | Uber One | Nectar Rewards | One Medical | Fertility Support | Fitness Reimbursement | Bike Membership | Professional Development Stipend | DoorDash and Catered Lunches | Parent Benefits | LinkedIn Learning | Gemini Enterprise Stack | Industrious Workspaces | Commuter Subsidies | Flexible Work Arrangement | Choice of Mac or Windows | Sponsored Company Events | Office Snacks and Beverages | Much More… Equal Employment Opportunity: Click Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Click Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Click Therapeutics in the U.S. In certain circumstances it may be advantageous to Click Therapeutics to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Click Therapeutics and the specific job and/or work site. Click Therapeutics may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Click Therapeutics in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Click Therapeutics support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Click Therapeutics. Recruitment Phishing Scams: Fake job advertisements and offers are increasingly appearing on the internet. If you have encountered a job posting or have been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond and report it to the Federal Trade Commission and the FBI at . Please be mindful of the following: * Click Therapeutics will only reach out to you through an "@clicktherapeutics.com" email address. * Other than your email address or telephone number, which you may provide via a job application portal, Click Therapeutics will never ask you to provide personally identifiable information about yourself (such as a Social Security Number or Driver's License Number) via a messaging application (like that used on the LinkedIn platform or Microsoft Teams). * Click Therapeutics will conduct interviews face-to-face over Zoom. * All job postings will be listed on the Click Therapeutics official career page.

Job DescriptionCompliance Investigator, Clinical ManufacturingAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Compliance Investigator, Clinical Manufacturing leads life-cycle investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventative actions to ensure compliance. • Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, field complaints and environmental excursion investigations., • Drive investigations to true root cause using appropriate investigation tools., • Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track CAPA plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Effectively utilize change management approach., • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process., • Champion CAPA plans and implementation., • Provide communication plan for on-going deviations & CAPA’s., • Effectively create and communicate CAPA plan to responsible parties., • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary., • Ability to abide by quality standards.REQUIREMENTS, • BS degree in a Quality/ Process related field., • Experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology or Bio-Pharma., • Root cause analysis experience in pharmaceutical or FDA regulated operation preferred., • Experience using e-Quality Management Systems preferred., • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Flexible and able to adapt to company growth and evolving responsibilities, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • Ability to work effectively as a team and independently., • Quality Systems Training (Deviation/CAPA)Working Environment While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. Non-absorbent laboratory coats are required, as well as latex (or a non-latex substitute) gloves. When working with potentially hazardous materials that may spray, aerosol, or otherwise contact skin or mucous membranes, face shields or goggles must be worn. Heavy cryo-gloves must be used when working with liquid nitrogen. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionCompany Description Leap Consulting Group supports clinical diagnostics and clinical research organizations through a full range of services supporting the end-to-end digital and technology needs of the lab, from the digital front door to the pre-analytical lab bench process (LIMS, instrumentation, automation, etc.), and all of the complex processes for report writing, revenue cycle, and patient engagement before and after testing. Leap provides turnkey services starting with strategic planning through full implementation and everything in between for CLIA, CAP, NYS CLEP, and FDA-compliant laboratories. Leap’s lab practice is led and staffed by veteran laboratory leaders from high-volume, high-complexity laboratories across the United States. In addition to lab-centric capabilities, Leap offers full capabilities across digital, cloud, and the rest of the IT ecosystems. Job Description We’re looking for experienced laboratory professionals — former bench technologists, R&D scientists, or lab operations specialists — who are excited to apply their laboratory expertise to be client-facing and working directly on client lab projects building the latest and greatest in clinical laboratory workflows and laboratory software system implementations. This is a hands-on, problem-solving role — you’ll work alongside scientists, engineers, and clinicians to make lab systems work better, not sell software or convince people why they need to do better - everyone is working together to make it better. This role is not a generic IT business analyst position — it’s designed for individuals with deep understanding of how labs actually function, from sample accessioning to reporting. If you have great IT analyst skills we need those too, but we are currently not hiring for those. Please do not apply here if you are not deeply experienced in clinical laboratory and/or LIMS. This is a role reporting into our Healthcare Practice Lead focused on supporting several laboratory initiatives including digital-front-doors, preanalytical systems, LIMS, lab automation, bioinformatics, revenue cycle, and other related needs. The role requires Laboratory Operations and/or Laboratory IT awareness, a background in digital transformation or information systems, and ideally exposure to clinical laboratory revenue cycle. The person in this role would be a smart, inquisitive, experienced clinical laboratory or health system technology business analyst or functional technical analyst. From Buy vs. Build Analysis, to System Sourcing projects, to big picture planning, and down to the real roll-up-your-sleeves implementation requirements gathering, technical design, and partnering with your software engineering peers to deliver solutions. In this position, you will work closely with Leap client’s business, clinical, and technology leaders to understand their needs, design and develop innovative solutions, and tackle complex challenges. The people in this role will help clients articulate their requirements, prioritize their needs, develop detailed specifications, and at times will lead implementations in Agile methodologies often supporting a mixed team of both Leap provided and client employee engineering resources. The ideal candidate will be well spoken, extremely organized, and able to succinctly capture every detail. You should also be able to ask questions to clients to ensure there are no gaps in the analysis conducted and be an effective communicator when there have been changes in the requirements. As is the nature of digital transformation consulting, the right people for this role find themselves adaptable and flexible in an environment where change is the only constant. The ideal candidate finds clarity in ambiguity and shifts priorities quickly as new client considerations, challenges, and opportunities arise. You should excel in managing projects, driving product development, and analyzing business needs, all while thriving in a fast-paced and collaborative environment. This role is a hybrid position based in our Bergen County NJ offices. Hybrid expectations include 4 days a week in office, 1 day remote, exclusive of client-related-travel which would be as required. Key Responsibilities: * Portfolio and Program Management: * Partner with clients to define a product or program vision, strategy, and roadmap in alignment with business goals and stakeholder needs * Business Analysis: * Able to understand complex lab workflows and communicating future state changes to developers * Perform gap analysis to identify discrepancies between current processes and desired outcomes * Translate bench-side workflows into system requirements * Document process maps that mirror the flow of specimens through the lab * Collaborate with engineers to digitize and automate R&D and QC processes * Be able to handle changes in workflow and how to address them when those blockers occur * Facilitate meetings to gather requirements, develop solution plans, and drive alignment with business stakeholders * Participate in detailed design sessions with the technical teams to define the implementation approach based on requirements gathered * Project Management: * Handle project ambiguity, complexity, and interdependencies with an organized and structured approach * Assess and prioritize new information and requirements, integrating them seamlessly into project deliverables * Identify and manage project risks and issues * Maintain project documentation, ensuring all project deliverables are documented, updated, and communicated effectively * Facilitation & Communication: * Maintain situational awareness and resolve conflicts efficiently to keep projects on track * Ensure clear and effective communication across all levels of the organization * Adaptability & Creative Problem Solving: * Demonstrate a proactive approach to identifying and addressing challenges * Embrace and manage chaos with a continuous learning mindset, adapting to evolving requirements and challenges * Detail Orientation & Strategic Vision: * Dive into the details to ensure precision and accuracy while maintaining a strategic, high-level perspective * Communicate complex technical concepts in a way that is accessible to non-technical stakeholders, effectively bridging the gap between technical and business perspectives * Stay strategic without losing the detail - it is an art more than a science * Execution & Results: * Demonstrate dependability and reliability with a focus on clear thinking and meticulous attention to detail * Produce detailed stories to drive development and be reliable for QA testing If you are an energetic and multifaceted professional who can embrace uncertainty, think on their feet, and effectively manage shifting priorities to drive projects forward, with the ability to navigate both technical details and strategic business goals, we encourage you to apply and help us drive impactful solutions for our clients! Keywords: LIMS, LIS, ELN, middleware, automation, genomics, pathology, molecular diagnostics, assay development, quality control, sample tracking, data integrity, CLIA, CAP, HL7, FHIR, lab workflow optimization Qualifications Minimum Qualifications: * Education: BA/BS Required * Experience: Minimum of 3-5 years working at the bench and/or as a Business Analyst or Functional Technical Analyst, preferably in a clinical laboratory * Be comfortable communicating in-person, by phone, over video, as well as collaboration chat tools such as Slack and Teams * Be a self-starting independent team player who is both professional and kind to colleagues and customers * Be tech savvy and ideally consider yourself 'fairly technical' * Proven experience in project management, product management, and business analysis * Strong facilitation, communication, and conflict resolution skills * Ability to manage multiple projects simultaneously and prioritize tasks effectively * Ability to manage complexity and ambiguity in a structured and organized manner * Demonstrated ability to drive results and deliver innovative solutions * Proficiency in discussing technical details and translating them into business value * Experience in performing gap analysis and creating business process flows Preferred Qualifications: Knowledge, experience, or proficiency in most or all of the following: * Acting as a liaison between technical operations and solutions providers * Documenting, analyzing, and recommending solutions to complex problems * Information Technology and Software Development business cycles * Healthcare Digital Physician and/or Patient Portals * Revenue Cycle Management * Laboratory Operations * Bioinformatics Additional Information • Be comfortable communicating in-person, by phone, over video, as well as collaboration chat tools such as Slack, • Be a self-starting independent team player who is both professional and kind to colleagues and customers

Job Description About Company: Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally. Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge. Job Description: RBA is looking for a FT Principal Investigator to join their team on a FT basis, M-F. The PI ensures adherence to protocol requirements, protecting the rights and welfare of study subjects, assuring the integrity of data generated at the site. In executing these position responsibilities, the Investigator is guided by and promotes the adherence to FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies. Responsibilities: Employee Mentoring Responsibilities • Work with Site Director, Study Coordinator, and Recruitment Manager to develop effective programs for study enrollment., • Work with Site Director to ensure that all staff are adequately trained and adhere to Standard Operating Procedure and working guidelines while performing study procedures on assigned studies., • Work with the Site Director to ensure the site has an adequate number of qualified staff, adequate facilities, and that the PI has adequate time to conduct the study., • Maintain a current, up to date curriculum vitae., • Maintain current licensure to practice., • Oversee all trial-related medical decisions or ensure that a qualified sub-investigator is available to do so., • Assess subject compliance with the test article and follow-up visits., • Assess subject's response to therapy., • Evaluate for adverse experiences per protocol guidelines., • Assist with rating scales., • Provide new information about the study or test article(s)., • Document deviations from the approved protocol., • Document and explain premature unblinding of the investigational product(s)., • Thoroughly familiar with the use of the investigational product(s)., • Education and experience, • M.D, D.O., or PhD required., • Requirements, • Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner., • Knowledgeable in medical terminology to communicate with physician office and laboratory staff., • Skilled in working with potential sponsors to place research with the site., • Work effectively with a staff of clinical professionals and creates a productive, satisfying work environment., • Demonstrate the ability to initiate activity as required and making appropriate decisions within the constraints of study protocols and, regulatory requirements., • Able to initiate or modify behavior to achieve desired outcomes despite environmental factors, priorities, or problems that might not be well defined or that are subject to change., • Experienced negotiation skills, • Formal presentation skills, • Ability to perform overnight business travel., • Excellent persuasive/selling skills., • Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines., • Knowledgeable in medical terminology, • Excellent communication skills (interpersonal, written, verbal), • Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)

Job DescriptionStandards & Practices Associate / Ad Review Specialist Location: New York, NY (Hybrid: In-office Mon-Thurs, Remote Fri) Pay Range: $28.75-$31.25 per hour About the Role: LHH is seeking a detail-oriented and analytical Standards & Practices Associate / Ad Review Specialist. In this role, you will review advertising content to ensure compliance with industry regulations and internal guidelines, working closely with internal and external stakeholders to maintain high standards of truthfulness, accuracy, and appropriateness in advertising. Key Responsibilities: • Review advertising materials at all stages of development for compliance with policies and guidelines., • Identify express and implied claims and evaluate supporting documentation such as studies, market research, and statistical data., • Maintain thorough records of all communications and documentation throughout the clearance process., • Spot potential issues related to taste, appropriateness, and community sensibilities., • Handle a high volume of claims and maintain organized histories.Basic Qualifications:, • Working knowledge or familiarity with advertising/marketing laws and regulations (FTC, FCC, FDA), clinical analysis, product testing, market research, and/or statistical analysis., • Excellent analytical, critical thinking, organizational, and communication skills (written and verbal)., • Minimum of 1 year of experience demonstrating strong analytical skills, writing ability, attention to detail, and stakeholder interaction., • Ability to prioritize and manage multiple assignments in a fast-paced environment., • Self-starter who can work independently and collaboratively.Preferred Qualifications:, • JD or advanced degree in marketing, science, research, or communications., • Familiarity with advertising regulations in industries such as pharmaceuticals, consumer goods, or gaming., • Experience in broadcast or advertising standards and/or production is a plus.Required Education:, • BA/BS degreeAdditional Information:, • Strong research and library skills are essential., • Interest in Standards & Practices and willingness to dive into complex issues., • Experience in political, pharma, or gaming sectors is helpful.Pay Details: $28.75 to $31.25 per hour Search managed by: Riley Grubbs Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Equal Opportunity Employer/Veterans/Disabled Military connected talent encouraged to apply To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: • The California Fair Chance Act, • Los Angeles City Fair Chance Ordinance, • Los Angeles County Fair Chance Ordinance for Employers, • San Francisco Fair Chance OrdinanceMassachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Job Description Responsibilities include but are not limited to: Preparing and submitting customs entries: This involves preparing the necessary documentation and data to US Customs and Border Protection (CBP) and other government agencies like the FDA, Fish & Wildlife Service (FWS), USDA, etc. Transmission of Customs Entries to U.S. Customs for import shipments Ensuring compliance: Verify accuracy of documents (commercial invoices, etc.) and ensure compliance with US Customs regulations.. Coordinating with various parties: Communicate and coordinate with internal / external customers, carriers, freight forwarders, customs officials and other agencies to ensure smooth clearance of good Problem-solving: Resolve documentation discrepancies, Customs exams, FDA holds, or other issues related to Customs clearance. Receiving, reviewing, and processing import documentation for an assigned base of accounts Preparing daily activities including: preparing delivery orders and coordinating the pickup and delivery of cargo, filing ISF (Importer Security Filing), answering emails Processing documents through the system and interface and providing updates and communications for internal and external customers to produce timely and compliant transactions Tracing key transaction information such as HBL, commercial invoice, and other required documents to determine if record is available Corresponding with overseas agents and clients Working with steamship lines/airlines/trucking companies to obtain quotations and handle the movement of freight Developing and maintaining excellent customer service to internal and external customers Preparing quotations Handling the files from A to Z Responsible to ensure legal compliance, provide import guidance and control within government rules and regulations. Job Requirements: Minimum 2- 4 years of experience in Import Customs Clearance operations Knowledge of current and historical Customs regulations, Harmonized Tariff Schedule, and related directives of government agencies (including but not limited to Environmental Protection Agency (EPA), Food and Drug Administration (FDA) and United States Agriculture Department (USDA) is a plus) Be able to work independently, multi-task, be a team player and work in a fast-paced environment Possess excellent written and verbal communication skills Have computer skills and knowledge of Microsoft Outlook, Excel, Word and Access Experience with the handling of hazardous materials a plus

Job Description Primary Responsibilities · Lead Clinical Pharmacology strategy across early and late stage development, integrating PK, PD, exposure–response, and biomarker data to inform dose selection, regimen, and overall study design. · Own model informed drug development (MIDD) plans (e.g., population PK, PBPK, and quantitative systems approaches) to optimize trial designs and decision points from first in human through pivotal phases. · Author and review CP deliverables for protocols, clinical development plans, IBs, SAPs, and regulatory documents (IND/IMPD/NDA/BLA/MAA), ensuring clarity, traceability, and compliance. · Drive analysis & reporting of PK/PD and exposure–response results (internal and CRO executed), ensuring scientific integrity, reproducibility, and timely insights for program teams and governance. · Establish bioanalytical strategy and standards (method selection/validation, sample handling, and data QC) in partnership with Translational Medicine and external labs/CROs. · Lead Health Authority interactions for CP topics; prepare briefing materials, address IRs, and represent the function in meetings with FDA, EMA, and other agencies. · Provide cross functional leadership with Clinical, Biostatistics, Data Science, CMC, and Regulatory to integrate quantitative evidence into go/no go decisions and portfolio prioritization. · Vendor selection and management for CP related CROs; define scopes, oversee execution, and ensure deliverables meet quality and timeline commitments. · Advance standards & governance (CDISC/ADaM for PK datasets, data pipelines, analysis reproducibility), championing best practices and inspection readiness for a GxP environment. · People collaborations (please note this is an individual contributor role): Must roll up sleeves and be a doer who wants to be into the details themselves. Mentor staff cross functionally and foster an inclusive, high-performance culture consistent with Immuneering values. Qualifications Education · Education: PhD or PharmD (or MS with significant industry experience) in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or related quantitative field required. · Experience: Minimum of 5+ years in biotech/pharma Clinical Pharmacology required, more years of experience is a plus, including end-to-end ownership of CP strategy, MIDD, and regulatory submissions across Phase 1–3. · Technical depth: • Population PK/PD modeling (NONMEM, Monolix), PBPK (Simcyp, GastroPlus), and exposure–response methods., • Bioanalytical method development/validation oversight and data integrity in GxP contexts. Soft skills: Strong experience working as an individual contributor. This is a single employee function expected to collaborate with internal functions for success. Exceptional scientific communication, cross functional influence, vendor management, and decision making in fast paced settings. Must embody Immuneering’s core values of: Data Rules, Humble, All In, Care and Own It (accountability). Physical Demands/ Working Conditions The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role. While extensive travel is not anticipated with this role, it is possible to perhaps up to 15% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission. Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam. Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.

Job Description Position hours: Monday-Friday, from 9 AM-5 PM. Lorenc Aesthetic Plastic Surgery Center is looking for a driven, goal-oriented, type-A player for a LPN / Research Assistant position to work in a private upscale cosmetic plastic surgery office Preforming LPN duties as well as assist our Study coordinator in our FDA Clinical trials. Job Details The job consists of assisting the doctor (plastic surgeon) to see patients during office hours, coordinating all surgical procedures, circulating in the OR, drawing blood and taking specimen samples as well as assisting the Study coordinator and taking delegation on FDA Study specific tasks. Candidate will also be operating our IV program which will require IV insertion and care. Certifications: The candidate will need a current LPN certification in addition to an IV certification. The ideal candidate has superb clinical and organizational skills. This is a front of the house position. Well groomed hair and clean manicure is required with a professional, polished, and friendly demeanor. This individual must have the ability to work independently with a proactive approach for time management and circulation of office tasks. Candidate MUST BE able to incorporate into a small intimate team and work as a team player with the willingness and ability to begin work as early as 8:30 and have the fexability to work past 5 PM when the occasion arises due to late patient care or surgeries. You must be available to work a MONDAY -FRIDAY 9-5 SHIFT. All candidates must have experience in Plastic/Cosmetic Surgery. Applicant should have experience with both front desk and back-office duties. WHAT YOU WILL DO: • Assist physician with patient examinations and office procedures (suture removal, set-up for minor surgeries, etc.), • Clean examination rooms, • Ensure examination rooms are fully stocked, take inventory assure all materials are available in advance, • Sterilize equipment, • Record patient and testing information, • Manage patient flow, • Dressing changes, • Logging specimens, • Laser/Micro-needling procedures, • Draw blood, • Answer phone calls, • Schedule and coordinate surgical appointments, • Work with the study coordinator to log subject information for FDA trails, • Use photo equipment particular to FDA trails to phot subjects progress in trails and log necessary updates, • take blood and specimen requirements for FDA Studies Pay: $65,000-$75,000 Expected hours: No less than 40 per week Company DescriptionZ. Paul Lorenc, MD, FACS (pronounced Lawrence), is a world-renowned board-certified aesthetic plastic surgeon who balances surgical expertise with an acute aesthetic sense of composition and proportion in the areas of facial rejuvenation, breast enhancement, and body contouring. After finishing medical school, Dr. Lorenc secured a position at the premier Surgical Residency Program at New York University Medical Center. Since establishing his private Park Avenue practice, Dr. Lorenc has been actively involved in research, development, and advancement of new aesthetic surgical and non-surgical techniques and procedures. He is internationally recognized for creating endoscopic techniques, most notably the endoscopic forehead lift, and holds numerous U.S. patents. As a recognized authority in facial anatomy, Dr. Lorenc is a pioneer in the development of the latest generation of dermal fillers and neurotoxins, leading various clinical trials for FDA approval in the U.S. Dr. Lorenc is often called upon to appear in front of the FDA in various capacities.Z. Paul Lorenc, MD, FACS (pronounced Lawrence), is a world-renowned board-certified aesthetic plastic surgeon who balances surgical expertise with an acute aesthetic sense of composition and proportion in the areas of facial rejuvenation, breast enhancement, and body contouring. After finishing medical school, Dr. Lorenc secured a position at the premier Surgical Residency Program at New York University Medical Center.\r\n\r\nSince establishing his private Park Avenue practice, Dr. Lorenc has been actively involved in research, development, and advancement of new aesthetic surgical and non-surgical techniques and procedures. He is internationally recognized for creating endoscopic techniques, most notably the endoscopic forehead lift, and holds numerous U.S. patents. As a recognized authority in facial anatomy, Dr. Lorenc is a pioneer in the development of the latest generation of dermal fillers and neurotoxins, leading various clinical trials for FDA approval in the U.S. Dr. Lorenc is often called upon to appear in front of the FDA in various capacities.

Job Description About Immuneering: Immuneering is a clinical-stage oncology company outpacing cancer to help patients outlive their disease. Our lead product candidate, atebimetinib (IMM-1-104) is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. Immuneering’s R&D team is based in a ~38,000 square foot lab and office facility in San Diego. The company also has offices in New York City and Cambridge MA. Immuneering has grown to more than 50+ employees, all working to apply their expertise, passion and creativity to improve the lives of people with serious diseases. Immuneering’s team works collaboratively and relentlessly, thinking across traditional boundaries to help shape the frontiers of drug development. General Summary of Duties: The Director, Regulatory, CMC (Chemistry, Manufacturing, and Controls) is a pivotal regulatory role responsible for developing and executing regulatory strategies for CMC activities across the company’s clinical product portfolio. This position ensures compliance with all applicable regulatory requirements and works cross-functionally to support product development, registration, and lifecycle management. A successful candidate will be a highly collaborative individual with strong interpersonal skills and will be an exceptional team player. Specific Duties, may include but not be limited to the following: · Develop and lead global CMC regulatory strategies for investigational and commercial products to ensure timely submissions and approvals. · Prepare, review, and submit CMC sections of regulatory documents including INDs, IMPDs, NDAs, BLAs, ANDAs, and supplements to FDA, and other regulatory authorities including the EMA. · Provide regulatory guidance on CMC matters to project teams, including manufacturing changes, process development, and technology transfers. · Monitor and interpret current and emerging CMC regulatory requirements, guidelines, and trends to proactively address potential impacts. · Represent Regulatory CMC in cross-functional teams and meetings, providing expertise and input on regulatory implications of manufacturing and quality changes. · Lead interactions and communications with regulatory agencies regarding CMC topics, e.g. pre-IND, end-of-phase, and pre-submission meetings. · Work with a sense of purpose to get work done using influence and good project management skills, fostering alignment with organizational goals. · Collaborate with Quality, CMC, R&D, Finance, Legal, Clinical and other internal departments to ensure regulatory compliance and readiness. Partner effectively and smoothly with CRO’s and consultants. Desired Skills and Qualifications · Bachelor’s degree in Chemistry, Pharmacy, Life Sciences, or related field required; advanced degree (PhD, PharmD, MS) highly preferred. · Minimum of 8+ years of experience in CMC regulatory affairs within the biopharmaceutical or pharmaceutical industry, including experience with small molecule development in oncology. More experience is a plus. · Proven track record of successful CMC submissions and approvals in the US and internationally. · In-depth knowledge of FDA, EMA, and ICH guidelines, regulations, and processes related to CMC. · Strong leadership, communication, and project management skills. · Must be focused on working collaboratively and within our values of: Data rules, All-in, Own it (Accountable), Caring and Humble. · Ability to work effectively in a collaborative, fast-paced environment. Location: Remote or Hybrid, if you live near an Immuneering office, regular Meet Ups are available. Physical Demands/ Working Conditions The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role. While extensive travel is not anticipated with this role, it is possible to perhaps up to [X]% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission. Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam. Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.

Job DescriptionDescription: Leading Freight Forwarder / NVOCC/ Customs House Broker/ Tank Container Operator, with locations in 24 countries and over 3300 employees strong, is seeking a highly motivated and organized individual to fill the position of Import Customer Service Representative – Customs Entry Writer in our Jersey City, NJ office. Responsibilities include but are not limited to: • Preparing and submitting customs entries: This involves preparing the necessary documentation and data to US Customs and Border Protection (CBP) and other government agencies like the FDA, Fish & Wildlife Service (FWS), USDA, etc., • Transmission of Customs Entries to U.S. Customs for import shipments, • Ensuring compliance: Verify accuracy of documents (commercial invoices, etc.) and ensure compliance with US Customs regulations., • Coordinating with various parties: Communicate and coordinate with internal / external customers, carriers, freight forwarders, customs officials and other agencies to ensure smooth clearance of good, • Problem-solving: Resolve documentation discrepancies, Customs exams, FDA holds, or other issues related to Customs clearance., • Receiving, reviewing, and processing import documentation for an assigned base of accounts, • Preparing daily activities including: preparing delivery orders and coordinating the pickup and delivery of cargo, filing ISF (Importer Security Filing), answering emails, • Processing documents through the system and interface and providing updates and communications for internal and external customers to produce timely and compliant transactions, • Tracing key transaction information such as HBL, commercial invoice, and other required documents to determine if record is available, • Corresponding with overseas agents and clients, • Working with steamship lines/airlines/trucking companies to obtain quotations and handle the movement of freight, • Developing and maintaining excellent customer service to internal and external customers, • Preparing quotations, • Handling the files from A to Z, • Responsible to ensure legal compliance, provide import guidance and control within government rules and regulations. Requirements: Job Requirements: · Minimum 2- 4 years of experience in Import Customs Clearance operations · Knowledge of current and historical Customs regulations, Harmonized Tariff Schedule, and related directives of government agencies (including but not limited to Environmental Protection Agency (EPA), Food and Drug Administration (FDA) and United States Agriculture Department (USDA) is a plus) · Be able to work independently, multi-task, be a team player and work in a fast-paced environment · Possess excellent written and verbal communication skills · Have computer skills and knowledge of Microsoft Outlook, Excel, Word and Access · Experience with the handling of hazardous materials a plus Our Benefits include: · Medical · Dental · Vision · Flexible Spending Account (Medical and Dependent Care) · 401(k) with company match · Company paid Life Insurance, Short-Term Disability and Long-Term Disability · Paid Holidays plus PTO and Sick Leave · Voluntary Time Off · Employee Assistance Program · Tuition Reimbursement · Employee Referral Program · Employee Discounts When applying, the candidate should include salary requirement. Background check required. Only those considered for the position will be contacted. Thank you for your interest.

Job DescriptionQuality Assurance Manager - ValidationAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. This position will report into the Associate Director of Quality Assurance responsible for the oversight and management of Quality Assurance Validation/Qualification activity. Responsible for managing the quality assurance validation activity such as development, implementation, and continuous improvement initiatives at two Allendale, NJ manufacturing sites. This role works to build, enhance, harmonize and manage quality assurance validation across sites and is responsible for finding solutions and coordinating change initiatives. Core responsibilities include, but not limited to, document management: review and approval of validation protocol, report, investigation report, assignment of CAPA, SOP development and revisions. Provides cross departmental support within Quality Assurance, as well as, collaborates with other Quality departments to support organizational and functional strategy. Develops and/or revises policies and procedures, as well as, supports operational excellence initiatives. Represents Quality Compliance in internal and external audits which may include interaction with regulatory health authorities and clients. • Functions as the sites Quality Assurance validation partner ensuring quality standards are enforced., • Partners closely with quality training staff in development of learning curriculum that drives compliance standards., • Oversees and manages the activities of validation team; provides leadership and direction to ensure that organizational and departmental goals are met., • Coordinates the investigation and closure of deviations with root cause analysis., • Ensures appropriate Corrective and Preventive Actions (CAPA) are initiated, implemented., • Manages end-to-end delivery of quality document assuring compliance of company's quality standards., • Reviews and approves GMP documents such as investigation report, CAPA, validation protocols and reports, SOPs, change controls, etc., • Reviews and proposes changes to quality agreements., • Participates in ongoing quality system improvement programs and initiatives. Establishes Quality Validation KPI Reporting and Continuous Improvement metrics., • Participates in internal audits, regulatory agencies, and client audits., • Provides technical information during tech transfer activities to ensure all quality requirements are met according to current industry standard., • Establishes departmental KPIs in alignment with organizational goals and objectives., • Plans and allocates resources to effectively staff and accomplish the work to meet departmental productivity and quality goals., • Plans, evaluates, and improves the efficiency of business processes and procedures to enhance speed, quality, efficiency, and output., • Makes business decisions that are financially responsible, accountable, justifiable, and defensible in accordance with organization policies and procedures., • Establishes and maintains relevant controls and feedback systems to monitor the operation of the department., • Determines staffing levels; recruits, interviews, selects, hires, and employs appropriate number of employees., • Provides oversight and direction to the employees in accordance with the organization's policies and procedures., • Coaches, mentors, and develops staff, including overseeing new employee onboarding and providing career development planning and opportunities., • Empowers employees to take responsibility for their jobs and goals. Delegates responsibility and holds staff accountable by providing regular feedback., • Fosters teamwork and cohesiveness among department members; expeditiously initiates conflict resolution when issues arise., • Creates a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization., • Leads employees to meet the organization's expectations for productivity, quality, continuous improvement, and goal accomplishment., • Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning., • Provides effective performance feedback through employee recognition, rewards, and disciplinary action, with the assistance of Human Resources, as necessary., • Maintains employee work schedules including assignments, job rotation, training, vacations and paid time off, coverage for absenteeism, and overtime scheduling., • Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, Instant Messaging (IM), and regular interpersonal communication., • Supervise 1-2 Direct Reports, • Other duties as assigned.REQUIRMENTS, • Bachelor of Science in biological sciences or other relevant field of study., • 5-10 years’ relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments. 3+ years of recent supervisory experience required. Experience in both clinical and commercial manufacturing is preferred., • Knowledge of FDA and EMEA regulations and a working knowledge of root cause analysis., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (investigation, validation/qualification reports, SOPs etc.), • Experience in organizing and leading teams., • Experience participating in health authority inspections and/or client audits., • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task team is essential, • Flexible and able to adapt to company growth and evolving responsibilities., • Training; GXP, SOP & WI training, Safety, • Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit., • Must be able to foster and work in a team-oriented environment., • Must be able to work infrequently on weekends, nights, and/or holidays as required/necessary., • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids., • Must be able to handle the standard moderate noise of the manufacturing facility., • Must be able to work in open floor plan environment and may work in close proximity to others., • Wheel-O-Vator available for use., • Small breakroom available. No on-site cafeteria available.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . Description: The R&D Engineer I/II is responsible for supporting product design and process development activities while ensuring compliance with all quality and regulatory requirements. The position has a scientific focus that includes implementation of formulation development through process development, prototype fabrication, and characterization, along with additional process evaluation and data generation through designed experiments. Process development in an R&D environment will be followed by qualification and technology transfer into manufacturing. Collaboration is a key aspect of this role, as the engineer will work within a multidisciplinary team of researchers and engineers. The position offers diverse opportunities in a collaborative cross-functional environment, requiring adaptability, flexibility, and a willingness to learn and innovate in the exploration of new technologies, new approaches, and techniques in pursuit of product/process robustness and innovation. The R&D Engineer I/II is expected to possess expertise in areas including, but not restricted to, polymer, chemical, material science, and process development and engineering. Additionally, they will assist in generating documentation essential for regulatory submissions, ongoing publication initiatives, and direct communication with the Head of Research regarding various tasks. This is a full-time, on-site position, located in Brooklyn, New York. This role is an independent contributor role (i.e. no direct reports). Level is dependent on experience. Responsibilities: • Oversee the planning, implementation, and analysis of experiments relevant to project objectives. Ensure the application of established scientific and engineering principles to solve complex problems and challenges innovatively and efficiently, adhering to rigorous scientific methodologies and protocols., • Create and execute product/process enhancement, and new product/process development plans., • Lead material/design/process changes and their implementation with well-documented research/analyses. Process and analyze results,, • Author protocols and reports including engineering studies and design verification/validation activities., • Aid in the development and execution of testing methods to aid in exploratory research, product/process development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes., • Prepare samples as required for manufacturing, testing, or other evaluations and data analysis., • Participate in voice-of-customer (VOC) labs and other user needs assessments., • Interface with external vendors, customers, and suppliers. Specify equipment and process requirements for developing and implementing new products, product improvement and new equipment/processes., • Support process and product transfers to manufacturing or CDMOs., • Maintain a laboratory notebook and other technical documentation according to required GLP/GMP guidelines., • Understand and prioritize process improvements, design experiments to make those improvements, and execute these plans in the laboratory., • Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation about research towards FDA/regulated authority submissions., • Provide support to the marketing and sales team, with the development of presentations, sales tools, and application data., • Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization. Required Qualifications • Education: BS in Chemical Engineering, Polymer Engineering, Material Science & Engineering, or related engineering discipline., • Minimum 4+ years previous experience in an industrial environment with a BS degree. (2 years minimum experience if advanced degrees)., • Proficiency as an adept experimentalist with hands-on experience in the product and process development of polymeric materials and their characterization in an R&D or manufacturing environment., • Mathematically inclined with strong analytical and problem-solving skills with the ability to be observant and to think creatively. Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies. Demonstrated ability to work independently as well as be a strong team contributor. Ability to effectively work within a team and cross-functionally to expedite the completion of critical project tasks., • Requires understanding of product/process design and engineering. Experience should include process development/validation and/or transfer/verification, protocols, and troubleshooting skills., • Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency on time., • Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills., • Working knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (cGMP) requirements., • Proficiency in the use of Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft PowerPoint is required., • Requires excellent written and verbal communication and presentation skills., • Legal authorization to work in the United States is required., • Physical Requirements include:, • Aseptic Gowning Qualification: Able to be successfully qualified for aseptic gowning, including successful respirator training., • Wear Appropriate Personal Protective Equipment (PPE):, • Be able to stand and walk for prolonged periods, with the ability to climb, balance, stoop, bend, reach, and handle equipment., • Ability to speak, listen, and understand verbal and written communication., • Possesses hand-eye coordination and manual dexterity for delicate manipulations., • Ability to lift up to 50 pounds occasionally and to carry, push, pull, or otherwise move objects., • Visual acuity is required for performing close and distant activities. Preferred Qualifications • An advanced technical degree (MS or PhD)., • ·Lab experience in an industry setting within cGMP-regulated environments., • Prior experience developing processes and scaling these up into manufacturing or CDMO, • Mechanical/electrical knowledge with the ability to troubleshoot processing equipment, • Six Sigma green belt or black belt certification preferred., • Experience implementing process and quality improvements in a manufacturing environment, • Work experience with the medical device or pharmaceutical industries, • Working knowledge of ISO 9001, ISO 13485:2003 and ISO 14971:200., • Working knowledge of FDA requirements as per 21 CFR 820. Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits • Competitive annual base salary range of $70,000 - $120,000, depending upon job level and qualifications, • Paid Vacation, Sick, & Holidays, • Monthly MetroCard Reimbursement, • 401(k) & Roth Retirement Savings Plan with company match up to 5%, • Work/Life Employee Assistance Program, • Company Paid Life and Short-Term Disability Coverage, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage

Job Description About Cleerly We're Cleerly – a healthcare company that's revolutionizing how heart disease is diagnosed, treated, and tracked. We were founded in 2017 by one of the world's leading cardiologists and are a growing team of world-class engineering, operations, medical affairs, marketing, and sales leaders. We raised $223M in Series C funding in 2022 which has enabled rapid growth and continued support of our mission. In December 2024 we received an additional $106M in a Series C extension funding. Most of our teams work remotely and have access to our offices in Denver, Colorado, New, York, New York, Dallas, Texas, and Lisbon, Portugal with some roles requiring you to be on-site in a location. Cleerly has created a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions with the goal of helping prevent heart attacks. Our technology goes beyond traditional measures of heart disease by enabling comprehensive quantification and characterization of atherosclerosis, or plaque buildup, in each of the heart arteries. Cleerly's solutions are supported by more than a decade of performing some of the world's largest clinical trials to identify important findings beyond symptoms that increase a person's risk of heart attacks. At Cleerly, we collaborate digitally and use a wide variety of systems. Our people use Google Workspace (GMail, Drive, Docs, Sheets, Slides), Slack, Confluence/Jira, and Zoom Video, prior experience in these areas is a plus. Role or department specific technology needs may vary and will be listed as requirements in the job description. While we are mostly a remote company, travel is required for some team meetings and cross function projects typically once per month or once per quarter, for some roles like sales or external facing roles travel could be up to 90% of the time. About the Opportunity We are seeking an accomplished Staff Product Manager to lead the release and launch of Cleerly's AI-powered products for cardiovascular health. The Product Manager will collaborate with cross-functional teams to define product requirements, prioritize features, and deliver innovative AI solutions that directly impact the diagnostic and prognostic care pathways for heart disease. This role requires a focus on understanding clinical needs, designing effective solutions, and making informed trade-offs to balance customer demands with technical feasibility. The Product Manager will be a primary contributor to product definition and will be responsible for prioritizing and articulating new opportunities in the marketplace and defining the product roadmap in alignment with the overall business objectives. Responsibilities • Lead the product roadmap for innovation products aligning with market demand, customer needs and company goals., • Engage with internal and external stakeholders, such as clinicians and AI scientists, to shape the product vision and direction; establish the voice of the customer funnel., • Write clear business and functional requirements that support development efforts while ensuring clinical relevance and regulatory alignment., • Understand the domain of diagnostic and prognostic care pathways for heart disease to guide product decisions., • Prioritize features and balance trade-offs between performance, feasibility, and business impact., • Collaborate with AI, regulatory, and engineering teams on implementation, from design and development reviews to launch, ensuring timely and high-quality delivery., • Work closely with product management and leadership teams to develop and support the go-to-market strategy., • Define, track, and interpret key product metrics to drive future product iteration, inform decisions and drive continuous improvement., • 10-12+ years in product and portfolio management, with hands-on experience developing and launching SaMD, or AI-driven healthcare solutions., • Bachelor's degree in Engineering, Biomedical Engineering, or a related technical field (MS or PhD a plus)., • Proven track record of leading the roadmap planning, end-to-end development, launch, and iteration of complex products in fast-paced or startup environments., • Deep understanding of clinical workflows and advanced imaging techniques, particularly in cardiology and radiology., • Track record of managing products through the full lifecycle, from concept to launch and beyond, while anticipating future needs and problems in the roadmap., • Strong research and analytical skills, a deep understanding of customer needs, and an ability to represent the customer as a stakeholder in detailed design team meetings., • Skilled at breaking down complex, ambiguous, or changing problems into clear product strategies and functional requirements., • Familiar with deep learning concepts, agile development methodologies (e.g., Agile, Scrum), and the regulatory environment (FDA, HIPAA, and global guidelines)., • Comfortable working cross-functionally including ML/AI, clinical, engineering, sales, regulatory, and marketing teams., • 12+ years in product and portfolio management, with hands-on experience developing and launching SaMD, or AI-driven healthcare solutions., • Experience leading cross-functional project teams including ML/AI,imaging, clinical, engineering, sales, regulatory, and marketing teams., • Prior experience in the cardiovascular field with base knowledge of cardiovascular diseases and procedures, to be able to engage in thoughtful discussions with key stakeholders., • Comprehensive knowledge of one or more medical imaging modalities (CT, MRI, Ultrasound, Fluoroscopy, etc.) and their role in diagnostic decision making, procedure planning and guidance., • Prior experience in complex healthcare or medical imaging workflow applications and enterprise imaging IT solutions., • Track record of driving strategic ideas, building business cases, developing product roadmaps, and securing executive alignment to deliver high-impact solutions. *Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.). Each role at Cleerly has a defined salary range based on market data and company stage. We typically hire at the lower to mid-point of the range, with the top end reserved for internal growth and exceptional performance. Actual pay depends on factors like experience, technical depth, geographic location, and alignment with internal peers. Working at Cleerly takes HEART. Discover our Core Values: • H: Humility- be a servant leader, • E: Excellence- deliver world-changing results, • A: Accountability- do what you say; expect the same from others, • R: Remarkable- inspire & innovate with impact OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER. We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation. By submitting your application, you agree to receive SMS messages from Cleerly recruiters throughout the interview process. Message frequency may vary. Message and data rates may apply. You can STOP messaging by sending STOP and get more help by sending HELP. For more information see our Privacy Policy (). All official emails will come from @cleerlyhealth.com email accounts. #Cleerly

Job Description WSAudiology is a global leader in the hearing aid industry. Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world. Part of WSAudiology group, HearUSA is on a mission to reframe the world of hearing care and set the highest standard in modern hearing health. With an extensive network of 4,000 independent Hearing Care Professionals and more than 350 centers in U.S., we strive every day to provide each individual with the care, knowledge and experience they deserve. ESSENTIAL DUTIES AND RESPONSIBILITIES: • Perform comprehensive hearing evaluation, hearing aid selection and fitting for all clients, employing best practices as defined by our client-centric service model of Simply Excellent Hearing Care. Meets minimum NPS score of 75., • Routinely demonstrates hearing aids as part of annual evaluations for clients to experience the sound and create the ‘wow’ moment of a personalized auditory simulation., • Evaluate test results in conjunction with client needs' assessment to make a personalized recommendation. Offers recommendation based on maximizing client benefits., • Perform routine follow-ups, clean and checks and hearing aid repairs. Maintain skills in ear impression taking, earmold modification and recommendation of ALD accessories., • Embody HearUSA's ambition of Changing Lives through Simply Excellent Hearing Care. Partner with the District manager, HCP Team Leads and L&D to adopt new initiatives aimed to grow your Center's revenue and change more lives., • Build a local community to proactively generate service demand and support marketing campaigns, such as to physicians and at health fairs. Successfully completes one community outreach and/or physician marketing per quarter., • Comply with all State license laws, FDA guidelines, WSA policies and HearUSA Quality Practice Guidelines (QPG). Operates in a HIPAA compliant manner, with documentation, outcome notes and referrals completed for all clients., • Engage in Continued Professional Development to maintain expertise in all aspects of service delivery, from consultative counseling to the selling, fitting and troubleshooting of current hearing aid technology., • Embraces our culture and values of Going Beyond Together, Pioneering for Better Solutions, and Passion for Impact.REQUIREMENTS:, • Experience in a similar Audiology or Hearing Aid Specialist role., • Active state license in Audiology and/or hearing aid dispensing., • 1-5 years of experience preferred., • Ability to pay close attention to detail with a high degree of accuracy., • Basic or advanced written communication skills., • Experience interacting with customers/clients., • Ability to communicate detailed or technical information clearly, accurately and concisely., • A structure of field support for your hearing center, • A professional development team of dedicated Regional Training Managers, • Continuing education, LinkedIn Learning & licensing reimbursement, • Career advancement pathways such as Hearing Care Provider and Client Experience Specialist Team Lead, Hearing Care Provider Advisory Board member, or District Manager, • Monthly Commissions, • CEUs & State Licensure Renewals for HCPs, • Defined Career Paths, • Sponsorship & Preceptor Opportunities, • President’s Club Incentives, • Employee Referral Program LIFESTYLE & BENEFITS:, • Comprehensive Benefits Package, • Paid Holidays & PTO Policy, • 401k Matching Program, • Tuition Reimbursement, • Employee, Family & Friends Hearing Aid Discount Program The Company provides equal opportunity to all employees and prospective employees without regard to race, color, creed, religion, national origin, ancestry, sex, age, physical or mental disability, marital status, pregnancy, genetic information, sexual orientation, gender identity, protected veteran or military status, or any other consideration not related to the person’s ability to do the job or otherwise made unlawful by federal, state, or local law.

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . Description: The Senior Medical Device Engineer is responsible for leading the design and development activities of new products and improving existing products in compliance with all quality and regulatory requirements. They will be responsible for authoring technical documents for the development of medical devices and combination products according to relevant Design Control regulations and standards. The person in this position will also be responsible for providing project-specific support, including technical analysis and review of supplier documentation as required. The position has a scientific focus that includes formulation development, product performance characterization, and implementation, including prototype design and fabrication, and data generation through designed experiments. The Senior Medical Device Engineer is expected to aspire for excellence with a bias toward action, willing to roll up their sleeves, get hands-on, and do what’s necessary to move projects forward in a fast-paced environment. They are committed to designing and developing products that dominate the marketplace and improve healthcare by partnering with our customers to drive purposeful innovation, resulting in best-in-class products. The Medical Device Engineer will work with a multidisciplinary team of researchers. This is a multi-faceted job in a highly collaborative environment across multiple functions that will require flexibility as well as an ability to learn about and develop new technologies and explore new techniques in pursuit of product innovation and robustness. Role level is contingent on experience, but this is not an entry level role.. This is a full-time, on-site position, located in Brooklyn, New York. Responsibilities • Create and lead experimentation for exploratory and/or product development research focusing on polymeric materials devices and their use., • Define new product functional requirements (design inputs/user needs) and evaluate the design's overall effectiveness, cost, reliability, and safety., • Lead cross-functional teams to develop new products, address design issues, and maintain existing designs., • Apply strong problem-solving skills to find solutions to complex problems., • Work independently to plan and schedule own activities necessary to meet project timelines., • Work cooperatively with, quality, manufacturing, regulatory, clinical, and marketing to ensure project success., • Lead the creation of design history file documentation through the new product development process., • Develop new implant and instrument designs utilizing Solidworks and modeling/detail design specifications., • Generate technical protocols/reports to support device safety and efficacy., • Invent/create concepts and designs and submit invention disclosures., • Ensure that all design activities adhere to FDA Quality System Regulations and ISO 13485 design control and risk management requirements. Lead material/design/process changes through a design control process, with well-documented research/analyses., • Author protocols and reports including development studies and design verification/validation activities., • Develop and execute test methods to aid in exploratory research, product development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes., • Exercise technical judgment in the design, execution, and interpretation of experiments within the scope of project responsibilities and ensure the use of professional concepts to solve complex problems in creative and effective ways, in conformance with scientific methods and procedures., • Prepare samples as required for testing, or other evaluations and data analysis, including in voice-of-customer (VOC) labs., • Interface with customers, suppliers, and internal cross-functional team members to develop specifications and coordinate prototype fabrication., • Maintain a laboratory notebook and other technical documentation to required GLP/GMP guidelines., • Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to research towards FDA/regulated authority submissions,, • Provide support to marketing and sales team, support the introduction of new technologies with the development of presentations, sales tools, formulations, and applications data, • Communicate results to the scientific community via published papers. Present research at academic/industry symposia as an external representative of the company., • Manage part-time staff as a research leader and mentor for ongoing research projects., • Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization., • Provide other project or product support as needed in order to support Cresilon’s business objective. Required Qualifications • BS in Chemical Engineering, Polymer Engineering, Material Science, Biomedical Engineering, Mechanical Engineering, or related scientific discipline., • A minimum of 5+ years of product development experience is required., • A minimum of 4 years of hands-on experience in new product research and development in a cGMP-regulated industry is required (work experience in the Medical Device field is strongly preferred), • Adept experimentalist with hands-on experience in product development of medical devices and their safety/efficacy characterization in an R&D environment., • Experience gathering user needs, translating them to technical inputs, and developing viable V&V (Design Verification and Validation) plans., • Experience leading complex product development initiatives from concept through product launch/release., • Good working knowledge of anatomy and surgical procedures is required., • Demonstrated ability to solve difficult technical problems and deliver practical solutions that meet the application requirements is required. This includes strong analytical, problem-solving, and decision-making skills with the ability to be observant and to think creatively., • Demonstrated ability to design experiments and analyze data with appropriate quality and statistical methodologies., • Demonstrated ability to work independently as well as effectively be a strong team contributor and work cross-functionally to expedite the completion of critical project tasks, • Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner., • Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills., • Requires strong leadership skills, excellent written and verbal communication and presentation skills., • Working knowledge of FDA requirements as per 21 CFR 820, ISO 9001, ISO 13485:2003, and ISO 14971:2007., • Working knowledge of Good Documentation Practices (GDP), and Good Manufacturing Practices (cGMP), • Good understanding of statistical tools and validation/verification techniques., • Proficiency in the use of Microsoft Excel, Microsoft Word, and Microsoft PowerPoint is required., • Legal authorization to work in the United States is required. Preferred Qualifications • An advanced degree (MS or Ph.D.) is strongly preferred., • Hands-on experience in product development with Class II and Class III medical devices., • Experience developing test methods and protocols/reports for safety and efficacy testing of implant and instrument designs., • Experience with IDE and PMA submissions., • Six-Sigma green belt or black belt certification Cresilon is an equal-opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits • Competitive annual base salary range of $100,000 - $160,000, depending upon job level and qualifications, • Paid Vacation, Sick, & Holidays, • Monthly MetroCard Reimbursement, • 401(k) & Roth Retirement Savings Plan with company match up to 5%, • Work/Life Employee Assistance Program, • Company Paid Life and Short-Term Disability Coverage, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage

Job Description About Immuneering: Immuneering is a clinical-stage oncology company outpacing cancer to help patients outlive their disease. Our lead product candidate, atebimetinib (IMM-1-104) is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. Immuneering’s R&D team is based in a ~38,000 square foot lab and office facility in San Diego. The company also has offices in New York City and Cambridge MA. Immuneering has grown to more than 50+ employees, all working to apply their expertise, passion and creativity to improve the lives of people with serious diseases. Immuneering’s team works collaboratively and relentlessly, thinking across traditional boundaries to help shape the frontiers of drug development. General Summary of Duties: The Sr Director, Quality Assurance is a strategic leadership role responsible for overseeing all aspects of Quality within the organization including the development, implementation, and management of GxP (cGMP, GCP, and GLP) quality systems. To accomplish this, the candidate should have a strong knowledge of relevant regulations and be able to work cross-functionally to ensure compliance of Immuneering’s ongoing development programs with local, state, federal, and international requirements. This position will be instrumental in developing a culture of quality, ensuring compliance with global regulatory requirements, driving continuous improvement in quality systems, and supporting the successful development, manufacturing, and commercialization of pharmaceutical products. A successful candidate will be a highly collaborative individual with strong interpersonal skills and will be an exceptional team player. Specific Duties, may include but not be limited to the following: · Develop, implement, and maintain GxP compliant quality systems and processes to ensure compliance with FDA, EMA, ICH, and global competent authority regulations and industry guidance · Lead quality audits, risk assessments, and investigations, ensuring timely resolution of quality issues. · Work with the company’s external suppliers and contract organizations to ensure consistent quality and compliance. · Prepare for and lead inspections by regulatory agencies and commercial partners, serving as the liaison between the Company and auditors, including reporting and follow-up to any finding · Oversee qualification and validation plans, assure proper batch releases and disposition. · Oversee resolution of any product concerns, including investigation, tracking and corrective action plans (CAPA) · Provide quality input on contracts and serve as the point person for negotiation of quality agreements. · Champion a culture of quality and continuous improvement across manufacturing and development operations. Desired Skills and Qualifications · Bachelor’s degree in biological sciences or related field, with at least 8 or more years experience in Quality Assurance or related fields within the pharmaceutical or biotechnology industry · Extensive knowledge of GxP (GMP, GLP, and GCP) regulations and guidelines, including FDA, EMA, and ICH requirements · Demonstrated leadership experience managing teams and complex projects. · Proven track record of successful CMC submissions and approvals in the US and internationally. · In-depth knowledge of FDA, EMA, and ICH guidelines, regulations, and processes related to CMC. · Strong leadership, communication, and project management skills. · Must be focused on working collaboratively and within our values of: Data rules, All-in, Own it (Accountable), Caring and Humble. · Ability to work effectively in a collaborative, fast-paced environment. Location: Remote or Hybrid, if you live near an Immuneering office, regular Meet Ups are available. Physical Demands/ Working Conditions The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role. While extensive travel is not anticipated with this role, it is possible to perhaps up to 15% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission. Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam. Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.

Job DescriptionSr. Manager Quality Assurance Validation Computerization Systems The incumbent will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • Bachelor’s Degree in a Scientific or Engineering discipline, • 8 + years of computerized system experience with IT compliance/validation/qualification activities., • 8 + years of experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • 10% travel required., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description BGB Group EVP, Market Access & Payer Marketing Our Agency BGB Group is a healthcare communications agency that offers a wide range of services, including traditional pharmaceutical advertising, promotional medical education, payer marketing, and consulting services. Known for excellence and professionalism, we're hired as strategic and creative partners by our biopharmaceutical clients to drive category/brand awareness and growth. Position Overview BGB is seeking a visionary and commercially driven EVP, Market Access & Payer Marketing Practice Lead to oversee and grow our Market Access business within the Communications division. This executive will be responsible for achieving revenue and profitability targets, driving strategic innovation, and expanding BGB's integrated communications offerings across Market Access, Medical Communications, and Advertising. This role is ideal for a dynamic leader with deep expertise in payer strategy, managed markets, and pharmaceutical commercialization, who thrives in a collaborative, cross-functional environment. Key ResponsibilitiesStrategic Leadership & Growth • Lead the Market Access & Payer Marketing practice, setting the strategic direction and ensuring alignment with BGB's broader Communications goals., • Own revenue and profitability targets for the Market Access business, including forecasting, budgeting, and performance tracking., • Identify and pursue new business and cross-selling opportunities within Medical Communications and Advertising practices to drive integrated growth across key accounts.Client Engagement & Delivery, • Serve as senior strategic advisor to clients, developing and executing market access strategies that align with brand objectives and payer needs., • Oversee the development of value propositions, payer messaging, and access tools including AMCP dossiers, PIE communications, and budget impact models., • Ensure excellence in client service, maintaining strong relationships across all levels of client organizations.Practice Development & Team Leadership, • Mentor and grow a high-performing team of account managers, strategists, creatives, and analysts across Market Access disciplines including value communications, HEOR, and patient access., • Foster collaboration across BGB's integrated service lines, ensuring seamless delivery of strategic, medical, and creative solutions., • Champion BGB's commitment to science-first communications, data-driven insights, and purpose-built programming.Innovation & Thought Leadership, • Stay ahead of evolving payer landscapes, regulatory shifts, and launch readiness best practices., • Represent BGB externally through thought leadership, including speaking opportunities, publications, and client engagement., • Drive innovation in access strategy, including digital enablement, predictive modeling, and AI-led scenario planning.Qualifications, • 15+ years of progressive experience in pharmaceutical/biopharmaceutical market access, payer marketing, brand strategy, or account leadership., • Proven track record of leading large-scale engagements and delivering measurable business impact., • Deep understanding of the U.S. market access landscape, including regulatory and compliance frameworks (AMA, PhRMA, FDA)., • Strong financial acumen and experience managing P&L for a business unit., • Exceptional leadership, communication, and collaboration skills. Salary Range: $225,000 - $300,000 The salary range provided is for the NYC-hybrid position, which requires occasional in-office presence, and represents what a potential hire may expect to earn in this role at BGB. For candidates in other locations, salary will be adjusted to reflect local market rates. Actual salary decisions will be influenced by several factors that we use to determine overall fit, including experience (both direct and indirect), education, training, demonstrated qualifications, and organizational need. Salary is only one component of the total rewards package offered at BGB Group. BGB Group is an equal opportunity employer. All applicants will be considered without regard to race, color, religion, sex, age, national origin, citizenship status, sexual orientation, disability, veteran status or any category or class of person protected by law.

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job overview: The Director, Commercial IT Systems leads the strategy and deployment of technology solutions that power our commercial launch and field operations. This role is central to building a scalable, compliant, and insight-driven IT ecosystem, enabling effective HCP engagement, data-driven decision-making, and the seamless execution of our commercial strategy. Location: Hybrid in our New York City office or remote on the east coast in the United States. Reports to: VP, Information Technology. Roles and responsibilities (Include but are not limited to): • Define and execute the Commercial IT roadmap aligned with launch milestones and business objectives, • Serve as the primary IT business partner to Sales, Marketing, and Market Access teams, • Work with the commercial team on the selection, implementation, and integration of commercial systems including CRM (e.g., Veeva, Salesforce), ERP, and data platforms. Lead the implementation and support of these systems, • Ensure interoperability across systems supporting HCP engagement, sample management, field force operations, and analytics, • Build and manage a high-performing Commercial IT team, including CRM admins, analysts, and support staff, • Manage vendor relationships, contracts, and performance for commercial technology platforms, • Ensure systems are implemented in compliance with GxP, DSCSA, GDPR, and other regulatory requirements, • Oversee validation and audit readiness for commercial systems, • Support mobile access, AI-powered coaching tools, and omnichannel engagement platforms for field reps, • Partner with Commercial Sales team to deliver tools that enhance rep productivity and HCP experience, • Enable commercial data integration and reporting to support forecasting, segmentation, and KPI tracking, • Collaborate with Commercial Operations team to enable actionable insights to commercial stakeholders Candidate Profile: • Bachelor's degree in Information Technology, Computer Science, or related field, • 10+ years of IT experience, with at least 5 years in pharmaceutical commercial systems leadership, • Proven track record implementing CRM, ERP, and field enablement tools in a regulated environment, • Strong understanding of pharmaceutical commercial operations, launch readiness, and compliance frameworks, • Experience managing cross-functional teams and external vendors, • Experience supporting a first-time commercial launch in biotech or pharmaceuticals, • Familiarity with Veeva Commercial Cloud, Salesforce Health Cloud, NetSuite, SAP, Oracle or other relevant commercial platforms, • Knowledge of serialization systems (e.g., EPCIS), DSCSA compliance, and sales tools 【For NYC】Compensation Description (annually): Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$180,000—$230,000 USDBenefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Job Description Hudson Regional Health System (HRHS) seeks a results-driven and collaborative laboratory leader to oversee diagnostic and clinical laboratory operations for Bayonne University Hospital and Secaucus University Hospital. The Director is accountable for ensuring regulatory compliance, service quality, and operational efficiency across both campuses, supporting HRHS’s mission of delivering exceptional, patient-centered care. Position Summary The Director manages all inpatient and outpatient laboratory functions for Bayonne and Secaucus hospitals, including technical operations, staffing, compliance, and financial performance. The position ensures consistency, quality, and innovation across both campuses while supporting HRHS’s broader laboratory strategy. This position reports directly to the System Chief Operating Officer. Key Responsibilities • Oversee daily operations of clinical laboratory services across Bayonne and Secaucus facilities., • Ensure full compliance with CLIA, CAP, Joint Commission, OSHA, FDA, and applicable state regulations., • Supervise laboratory leadership teams, including supervisors, and technical personnel., • Maintain appropriate staffing, scheduling, and budgetary controls to ensure cost-effective performance., • Collaborate with hospital executives, medical directors, and clinical departments to support patient care initiatives., • Lead continuous quality improvement and performance optimization efforts across both sites., • Manage equipment procurement, service contracts, and laboratory supply chains., • Partner with IT and system teams to standardize data, reporting, and laboratory information systems., • Track and report KPIs, turnaround times, and quality metrics to system leadership., • Serve as the administrative and operational leader for laboratory services at Bayonne and Secaucus campuses., • Collaborate directly with the System COO and other hospital executives to align goals and share best practices., • Work closely with other HRHS laboratory leaders to advance system standardization and integration., • Bachelor’s degree in Clinical Laboratory Science, Medical Technology, or related field required; Master’s degree preferred., • Current licensure and national certification (ASCP, NCA, or AMT) required., • Minimum 7 years of progressive experience in laboratory management, including multi-site leadership preferred., • Reference Lab experience preferred., • Deep understanding of regulatory requirements, budget management, and process improvement methodologies., • Exceptional interpersonal and leadership skills, with the ability to collaborate effectively across departments.

Job DescriptionQuality Assurance Compliance SpecialistAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the Associate Manager of Quality Compliance. Responsible to perform Quality Assurance Compliance activities in support of Quality Systems and/or client procedures, including but not limited to, document. management: investigations, CAPA, SOPs, qualification and validation reports, QC data. Supports Quality management with various department, organizational and operational excellence initiatives. Generally, exercises independent judgment, within generally defined practices and policies, when selecting methods and techniques for obtaining solutions. This role supports internal and external audits which may include interaction with Health Authorities and clients. • Liaises with relevant functional groups (Operations, Facilitates, QC, EH&S) to provide guidance through all stages of the investigation / CAPA processes., • Develops and communicates investigation strategy to key stakeholders., • In order to close investigation and CAPA, collect necessary information from appropriate department to close in quality system and maintain investigation and CAPA log, • Reviews and approves investigations and CAPAs;, • Conducts weekly status update meetings with cross functional departments and other stakeholders., • Monitors DR/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality & business review to management on periodic basis., • Prepares and issues change control as necessary., • Adherences and champions to all compliance regulations as required by regulatory agencies and per the Company’s processes and procedures., • Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations., • Conducts trend analysis of compliance related metrics such as deviations and CAPAs., • Performs supplemental investigations and/or participates in project teams or assignment as necessary., • Support in agency, internal and/or client audits., • Functional/Technical Skills: has the functional and technical knowledge and skills to do the job at a high level of accomplishment., • Decision Quality: Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions., • Drive for Results: Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results., • Written Communication: Able to write clearly and succinctly in a variety of communication settings and styles., • Peer Relationships: Quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers.REQUIREMENTS, • BS biological sciences or other relevant field of study., • 5 years’ + experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Familiar with FDA, ISO, and other regulatory agency guidelines., • Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required., • Working knowledge and technical understanding of aseptic manufacture of biologics preferred., • Experience in both clinical and commercial manufacturing is preferred., • Experience in supporting health authority inspections and/or client audits preferred., • Minimum Required Training (optional); GXP training, SOP & WI training, Safety Training, • Understanding and comprehension of quality system applications.Working Environment Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit.Must be able to work in a team-oriented environment.Must be able to work occasional weekends, nights, and/or holidays as required/necessary.May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids.Must be able to handle the standard moderate noise of the manufacturing facility.Must be able to work in open floor plan environment and may work in close proximity to others.Wheel-o-Vator available for use.Small breakroom available. No on-site cafeteria available.Able to utilize equipment in manufacturing are as well QC laboratories.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionThe incumbent will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • Bachelor’s Degree in a Scientific or Engineering discipline, • 8 + years of computerized system experience with IT compliance/validation/qualification activities., • 8 + years of experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • 10% travel required., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Salary: $90000 - $100000 / year What makes FLIK click What makes FLIK click? Our people. The decisions, actions and attitudes of our associates earn the trust and loyalty of our clients every day. We know how to pick them and we know how to grow them. It starts with hiring people who share our passion for food and hospitality. Once we find the right talent, we encourage, value and recognize their contributions. We keep our people renewed, excited and engaged by providing hands-on training and educating them about the latest trends. We give them a stake in successfully raising the bar. Our people love what they do and they love sharing their passion. Join our team and see the FLIK difference. Where a job isn’t merely a job but the start of a career where you can flourish. Job Summary The Quality Assurance Manager is responsible for development and maintenance of all QA programs, meeting USDA, FDA and customer requirements and ensuring the quality and safety of supplied goods. Must have strong knowledge in Preventive Controls for Human Food. A strong background in manufacturing, quality assurance and strong understand of FSMA is a must. Key Responsibilities: • Contributes to development and execution of product food safety and quality programs to support the organization’s goals of operational excellence, customer/client satisfaction, financial performance, market leadership, and preferred employer., • Responsible for developing and on-going maintenance of the Food Safety Plan. Must be able to identify deficiencies and implement new strategies., • Ensures all HACCP, GMP’s, sanitation preventive controls, supply chain preventive controls and all other prerequisite food safety standards are met according to USDA, FDA, FSIS, FSMA and corporate requirements., • Must have extensive knowledge of the facilities process flow and engage personnel in all areas of food safety and quality within the flow., • Manages Allergen Preventive Controls Program ensuring accurate allergen labeling on finished food products and prevention of allergen cross contact., • Manages the written recall program., • Oversees all food safety audits conducted by government and third party agencies., • Responds to customer safety and quality concerns as needed. Preferred Qualifications: • At least 6 years of directly related experience required in Quality Assurance and Food Safety manufacturing role., • Experienced in prepared foods manufacturing a plus., • HACCP program development and FSMA is a must., • HACCP certification, Preventive Controls for Human Food (PCQI) and GFSI auditor certification a plus., • Strong understanding of required third party audit and GFSI audit scheme programs and standards., • Working knowledge of food processing and distribution regulations, i.e. FDA and USDA/FSIS, and industry practice., • Experience developing and motivating personnel., • Track record of food safety/QA success in any of the following focus areas a plus: meat, poultry, seafood, processed foods, distribution, proprietary/private-label product development and/or monitoring., • B.S. degree in food technology, food science, or related curriculum and/or experience required., • Ability to function effectively within a fast-paced, diverse and evolving corporate culture is necessary., • Proficient in Microsoft Office applications and ability to learn various software and web-enabled programs., • Must be a strong, persuasive communicator and coach, with the ability to relate to other professionals, peers, and field operators, both technical and non-technical. Flik is a member of Compass Group USA Click here to Learn More about the Compass Story Compass Group is an equal opportunity employer. At Compass, we are committed to treating all Applicants and Associates fairly based on their abilities, achievements, and experience without regard to race, national origin, sex, age, disability, veteran status, sexual orientation, gender identity, or any other classification protected by law. Qualified candidates must be able to perform the essential functions of this position satisfactorily with or without a reasonable accommodation. Disclaimer: this job post is not necessarily an exhaustive list of all essential responsibilities, skills, tasks, or requirements associated with this position. While this is intended to be an accurate reflection of the position posted, the Company reserves the right to modify or change the essential functions of the job based on business necessity. We will consider for employment all qualified applicants, including those with a criminal history (including relevant driving history), in a manner consistent with all applicable federal, state, and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, and the New York Fair Chance Act. Applications are accepted on an ongoing basis. Flik maintains a drug-free workplace. Associates at Flik Hospitality are offered many fantastic benefits. • Medical, • Dental, • Vision, • Life Insurance/ AD, • Disability Insurance, • Retirement Plan, • Paid Time Off, • Holiday Time Off (varies by site/state), • Associate Shopping Program, • Health and Wellness Programs, • Discount Marketplace, • Identity Theft Protection, • Pet Insurance, • Commuter Benefits, • Employee Assistance Program, • Flexible Spending Accounts (FSAs), • Paid Parental Leave Req ID: 1468739 Flik Hospitality Group JEANNE M LANE [[req_classification]]

Job DescriptionABOUT PROJECT HEALTHY MINDS Project Healthy Minds is a mental health tech non-profit startup. We are pioneering a first-of-its-kind model: applying technology to address one of the biggest social issues of our time: the growing mental health crisis. We believe in a simple but profound idea: that it should be as easy to find mental health services as it is to book a flight or a restaurant reservation. That's why we're building the world’s first digital marketplace for finding mental health services that are right for you. To do that, we work with some of the most inspiring and influential leaders in America - business titans, tech entrepreneurs, clinicians and scientists, musicians, artists, athletes, media stars, policymakers, and more - because we believe that the world's most complex challenges require interdisciplinary teams and solutions. We are backed by a powerhouse of industry-leading Board of Directors and Advisory Council Members who are passionate, hands-on, and dive into the important work with us. Learn more at projecthealthyminds.com and @projecthealthyminds on social. ABOUT THE ROLE WHAT WE’RE LOOKING FOR: Creating best-in-class donor data systems is integral to supporting Project Healthy Minds’ mission. The Development Operations Associate will be a key contributor responsible for developing and continuously improving all fundraising operations. This candidate will provide ongoing administrative support and Salesforce expertise that lead to analytically-driven and strategic operational outcomes. Additionally, they will manage all individual funders who give less than $5K, gaining front-end development experience through donor stewardship and cultivation efforts. We’re looking for a self-starter who is eager to focus on setting a high standard for gift administration, information management, data automation, and reporting throughout the development process. HOW YOU’LL CONTRIBUTE:• As the lead creator and driver for all gift processing systems, execute daily gift entry and acknowledgement letters.• Update and manage gift acknowledgement letters and recognition plans with the Development team.• Manage relationships with funders giving less than $5K, including donor stewardship, cultivation, and communications. • Lead large fundraising campaigns such as the spring appeal, fall appeal, and Giving Tuesday to creatively engage small funders and nurture them into long-term champions.• Research donor biographical information, keeping all donor records up-to-date.• Advise on tech stack and integrate data from third-party platforms into Salesforce.• Develop and maintain a dynamic donor segmentation system within Salesforce, tailored to identify and categorize major gift prospects based on giving history, engagement levels, and potential capacity to streamline targeted fundraising initiatives and personalized donor strategies.• Initiate and manage a continuous improvement program for fundraising technologies and platforms, ensuring they remain cutting-edge and effectively meet the organization's and its donors' evolving needs.• Provide regular donor reports to the team, from at-a-glance summaries to robust analyses, converting data into key decisions. • Create dashboards to capture and maintain all events and communications in Salesforce.• Partner with the Development & Events teams to create event registration, check-in, and gratitude procedures. • Create and maintain documentation for all Development Operations processes and protocols.• Act as a liaison with the CFO to complete revenue reconciliation as needed and assist with annual external audits.• Provide excellent customer service to supporters via phone and email inquiries. • Collaborate on the coordination of new supporter cultivation and existing supporter stewardship.• Work closely with the CEO to capture donor meeting notes and action items.• Train all team members on application use. • Play a key role in the donor stewardship plan, ensuring donors and prospects are communicated with regularly. • Support all other day-to-day operations that enable a successful fundraising strategy. ABOUT YOU OUR IDEAL CANDIDATE IS:• Mission-driven – You are passionate about our work and eager to build something brand new in the mental health non-profit space.• Data-driven – You are analytical and metrics-driven. You might even say you’re obsessed with analyzing, interpreting, and leveraging complex data sets to scale impactful solutions. • Detail-oriented – When it comes to your work, you are hyper-organized with a keen attention to detail. • Proficient in Salesforce and Excel – Your past work experience has included building cross-functional donor data processes. • Collaborative – No task is too big or too small. You thrive in an entrepreneurial, fast-paced environment and know when to take ownership and when to ask for help.• A lifetime learner – You identify as a critical thinker and deep listener. You’re eager to ask questions and apply learnings skillfully.• Adaptable – You are highly comfortable in a changing environment.• A strong communicator – Building relationships is one of your core competencies. You care about delivering top-notch customer service, demonstrating that you care about resolving all stakeholder’s data needs. • Experienced – Bachelor’s degree and at least 2-4 years of experience preferred. WHAT WE OFFER

Job Description We are Licensed Customs House Brokers looking for a highly motivated, customer service oriented data entry clerk. The hours are from 8:30 to 5:00. Import Entry Specialist - TCRS4556 HIGH LEVEL OVERVIEW The Import Entry Specialist is responsible for the timely and accurate filing of customs entries ensuring compliance with CBP and other government regulations. This is an on-site position based in Englewood Cliffs, NJ. EXPECTATIONS • Prepare, review, & process import entry documentation for air/ocean shipments and border crossings, • Work with CBP and other government agencies to resolve any compliance issues, holds, or queries, • Work with internal and external partners to provide timely clearance updates, • Maintain and manage client product database with HTS classification, • Stay current with changes to regulations and understand the impact to import entry processes, • Knowledge of U.S. Customs regulations; HTS Classification, COO, Valuation, • 3 years’ Customs Brokerage experience preferred, • Strong attention to detail, accuracy in data entry, and time-management skills, • Organizational skills and the ability to multitask in a fast-paced environment, • Understanding of FDA, DOT, and LACEY import regulations, • Knowledge of trade automation tools; CargoWise, ACE, etc., • Experience with import entry software, ideally Decartes/NetCHB, • Experience in Microsoft applications- Excel, Word, PowerPoint, OutlookCompany DescriptionLicensed Customs House BrokerLicensed Customs House Broker

Job Description Datavant is a data platform company and the world's leader in health data exchange. Our vision is that every healthcare decision is powered by the right data, at the right time, in the right format. Our platform is powered by the largest, most diverse health data network in the U.S., enabling data to be secure, accessible and usable to inform better health decisions. Datavant is trusted by the world's leading life sciences companies, government agencies, and those who deliver and pay for care. By joining Datavant today, you're stepping onto a high-performing, values-driven team. Together, we're rising to the challenge of tackling some of healthcare's most complex problems with technology-forward solutions. Datavanters bring a diversity of professional, educational and life experiences to realize our bold vision for healthcare. Datavant is seeking a strategic and hands-on Director of Quality to lead product and supplier quality assurance efforts within our Life Sciences business unit, which includes the Datavant Connect and Aetion Evidence Platform. These platforms deliver regulatory-grade real-world data (RWD) solutions through tokenization, data linkage, and privacy-preserving analytics. As Director of Quality, you will own the implementation and evolution of GxP-aligned quality practices that support regulated data services and software. This includes oversight of software validation, privacy compliance, supplier qualification, and audit readiness. You will also lead a team of quality specialists and partner cross-functionally with Product, Engineering, Security, Privacy, and Customer Assurance to ensure that we meet or exceed regulatory expectations and customer trust standards. This role is essential to operationalizing Datavant's Quality Management System (QMS) across internal and external stakeholders and enabling continued growth in regulated RWD and evidence generation environments. What You Will Do • Lead the development and continuous improvement of Datavant's QMS across Life Sciences products and supplier relationships, ensuring GxP and privacy compliance., • Manage and mentor a team of quality specialists responsible for core functions such as CAPA, internal audits, validation, and supplier monitoring., • Serve as the primary quality liaison to product development teams (Connect and Aetion), providing guidance on SDLC quality controls, validation strategies (GAMP 5, Part 11), and regulatory risk mitigation., • Oversee supplier qualification and re-evaluation processes, including risk-based assessments, audit coordination, and performance monitoring., • Establish and maintain quality metrics (e.g., CAPA closure, audit readiness scores, supplier performance) and drive continuous improvement initiatives., • Support readiness for and participation in customer audits and external assessments (e.g., pharma clients, CROs, regulatory partners)., • Partner with Security and Privacy teams to align product and supplier practices with frameworks like HIPAA, GDPR, and FedRAMP., • Lead or support periodic management reviews of the QMS and contribute to strategic quality planning and resource allocation., • Ensure clear documentation and traceability across all quality activities, systems, and changes in compliance with FDA 21 CFR Part 11 and ICH E6(R3)., • 8+ years of experience in quality, compliance, or regulatory roles within life sciences, digital health, or regulated software organizations., • Strong working knowledge of relevant regulations and frameworks, including FDA 21 CFR Part 11, GAMP 5, ISO 9001, ICH E6(R3), HIPAA, and GDPR., • Proven leadership in scaling and operationalizing a QMS in a SaaS, RWD, or GxP context., • Experience managing and mentoring cross-functional teams., • Demonstrated success overseeing validation, supplier oversight, internal audits, and CAPA management., • Deep understanding of data governance, privacy, and security best practices., • Experience interacting with external auditors, customer compliance teams, or regulatory agencies., • Prior experience supporting real-world data (RWD) platforms or evidence generation technologies used in regulatory submissions., • Background working in or with tokenization, health data linkage, or privacy-enhancing technologies., • Experience interfacing directly with pharmaceutical, biotech, or CRO quality teams., • Training or certification in Six Sigma, ISO Auditing, or software validation methodologies., • Familiarity with supplier portals, quality dashboards, or eQMS platforms (e.g., Veeva, MasterControl)., • Experience contributing to industry working groups on quality, data integrity, or health data compliance. #LI-BC1 We are committed to building a diverse team of Datavanters who are all responsible for stewarding a high-performance culture in which all Datavanters belong and thrive. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. At Datavant our total rewards strategy powers a high-growth, high-performance, health technology company that rewards our employees for transforming health care through creating industry-defining data logistics products and services. The range posted is for a given job title, which can include multiple levels. Individual rates for the same job title may differ based on their level, responsibilities, skills, and experience for a specific job. This role is eligible for additional variable compensation. The estimated base salary range (not including variable pay) for this role is:$165,000—$230,000 USD To ensure the safety of patients and staff, many of our clients require post-offer health screenings and proof and/or completion of various vaccinations such as the flu shot, Tdap, COVID-19, etc. Any requests to be exempted from these requirements will be reviewed by Datavant Human Resources and determined on a case-by-case basis. Depending on the state in which you will be working, exemptions may be available on the basis of disability, medical contraindications to the vaccine or any of its components, pregnancy or pregnancy-related medical conditions, and/or religion. This job is not eligible for employment sponsorship. Datavant is committed to a work environment free from job discrimination. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. To learn more about our commitment, please review our EEO Commitment Statement here. Know Your Rights, explore the resources available through the EEOC for more information regarding your legal rights and protections. In addition, Datavant does not and will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay. At the end of this application, you will find a set of voluntary demographic questions. If you choose to respond, your answers will be anonymous and will help us identify areas for improvement in our recruitment process. (We can only see aggregate responses, not individual ones. In fact, we aren't even able to see whether you've responded.) Responding is entirely optional and will not affect your application or hiring process in any way. Datavant is committed to working with and providing reasonable accommodations to individuals with physical and mental disabilities. If you need an accommodation while seeking employment, please request it here, by selecting the 'Interview Accommodation Request' category. You will need your requisition ID when submitting your request, you can find instructions for locating it here. Requests for reasonable accommodations will be reviewed on a case-by-case basis. For more information about how we collect and use your data, please review our Privacy Policy.

Job Description About Cleerly We're Cleerly – a healthcare company that's revolutionizing how heart disease is diagnosed, treated, and tracked. We were founded in 2017 by one of the world's leading cardiologists and are a growing team of world-class engineering, operations, medical affairs, marketing, and sales leaders. We raised $223M in Series C funding in 2022 which has enabled rapid growth and continued support of our mission. In December 2024 we received an additional $106M in a Series C extension funding. Most of our teams work remotely and have access to our offices in Denver, Colorado, New, York, New York, Dallas, Texas, and Lisbon, Portugal with some roles requiring you to be on-site in a location. Cleerly has created a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions with the goal of helping prevent heart attacks. Our technology goes beyond traditional measures of heart disease by enabling comprehensive quantification and characterization of atherosclerosis, or plaque buildup, in each of the heart arteries. Cleerly's solutions are supported by more than a decade of performing some of the world's largest clinical trials to identify important findings beyond symptoms that increase a person's risk of heart attacks. At Cleerly, we collaborate digitally and use a wide variety of systems. Our people use Google Workspace (GMail, Drive, Docs, Sheets, Slides), Slack, Confluence/Jira, and Zoom Video, prior experience in these areas is a plus. Role or department specific technology needs may vary and will be listed as requirements in the job description. While we are mostly a remote company, travel is required for some team meetings and cross function projects typically once per month or once per quarter, for some roles like sales or external facing roles travel could be up to 90% of the time. About the Team You will join our expert Computational Imaging team, where we develop sophisticated algorithms to enhance and improve medical imaging. We are focused on improving the quality and clinical value of medical images, creating powerful, extra software components that correct artifacts, standardize data, and ensure the utmost precision before the final analysis. Our work is essential for elevating the reliability and accuracy of Cleerly's regulated products. Responsibilities • Research and develop state-of-the-art AI and non-AI algorithms for coronary CT imaging applications., • Translate product and clinical requirements into algorithmic specifications in collaboration with Product and Clinical teams., • Partner with Regulatory Affairs to support regulatory submissions (e.g., 510(k), De Novo,PCCP), including generating evidence and documentation., • Collaborate with engineering teams to deploy AI and non-AI based solutions in clinical practice., • Communicate findings and strategy to internal stakeholders and leadership through clear technical documentation, presentations, and demos., • Contribute to intellectual property development through patents and scientific publications., • Ph.D. in Computer Science, Data Science, Biomedical Engineering, Biomedical Imaging, or a related technical field, with 5+ years combined postdoc and/or industry experience; OR an M.S. with 8+ years of relevant experience., • R&D experience in medical image processing, demonstrating subject matter expertise in deep learning methods for image quality enhancements, optical flow analysis and CT harmonization., • Proven track record of publications in top-tier medical imaging or computer vision conferences and journals (e.g., MICCAI, IEEE TMI, CVPR, Medical Image Analysis)., • Strong experience in Python, Tensorflow and pytorch., • Prior experience with ITK, OpenCV, VTK., • Excellent interpersonal, cross-functional, and cross-cultural collaboration skills., • 5+ years of industry experience in AI-based medical device development or clinical deployment., • Experience supporting FDA regulatory submissions for ML-based software, including familiarity with De Novo, 510(k), and PCCP pathways. *Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.). Each role at Cleerly has a defined salary range based on market data and company stage. We typically hire at the lower to mid-point of the range, with the top end reserved for internal growth and exceptional performance. Actual pay depends on factors like experience, technical depth, geographic location, and alignment with internal peers. Working at Cleerly takes HEART. Discover our Core Values: • H: Humility- be a servant leader, • E: Excellence- deliver world-changing results, • A: Accountability- do what you say; expect the same from others, • R: Remarkable- inspire & innovate with impact OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER. We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation. By submitting your application, you agree to receive SMS messages from Cleerly recruiters throughout the interview process. Message frequency may vary. Message and data rates may apply. You can STOP messaging by sending STOP and get more help by sending HELP. For more information see our Privacy Policy (). All official emails will come from @cleerlyhealth.com email accounts. #Cleerly

Job DescriptionAbout CookUnity: Food has lost its soul to modern convenience. And with it, it has lost the power to nourish, inspire, and connect us. So in 2018, CookUnity was founded as the first-of-its-kind platform that connects the world with the source of truly great food: chefs. Today, CookUnity delivers 50 million meals a year from the industry's best chefs to homes all over the country. Fresh. Ready-to-eat. And crafted with the passion that nourishes body and soul. Unwilling to stop there, CookUnity is expanding beyond delivery to become an ever-innovating marketplace focused on our singular mission: empower Chefs to nourish the world. If that mission has you hungry in more ways than one, you've found the right job posting. The Quality Assurance Associate performs activities associated with quality control of meals. You will be responsible for ensuring the safety of our meals in accordance with our HACCP and FDA standards. Responsibilities: • Complete Pre-Op inspection form, • Oversee food production and ensure all Chefs are adhering to the rules and regulations of the CU Chef agreement, • Pulls up daily menu, items to be cooked per Chef and enters each component into the Cooking/Cooling Log, records time and temperature of each dish, check weights prior to start to ensure accuracy, • Communicate kitchen rules to Chefs as needed- mask wearing, gloves, hairnets, proper hand-washing, cleaning of equipment, sanitizing of prep stations, etc., • Ensure all items going into walk-in are labeled appropriately (Labels must include Chef Name, Product Name and Date), • Ability to work in a cold prep area kept at 35 degrees, • Ability to regularly lift and move up to 25 pounds without assistance, • Stand for long periods of time, • High school diploma or equivalent, • Previous experience in food safety or quality control, • Bilingual (Spanish), • Food Handlers Certification or willing to complete upon hiring, • Sense of urgency, • Attention to detail CookUnity is an Equal Opportunity Employer. We are dedicated to creating a community of inclusion and an environment free from discrimination or harassment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, citizenship status, protected veteran status, genetic information, or physical or mental disability. A quick note for all candidates We've recently seen an increase in recruitment scams across the industry, and we want to make sure you (and your data) stay safe while applying to CookUnity. We also want you to know that we take this seriously — sometimes, as part of our process, we may ask for a brief "proof of humanity" to confirm that we're connecting with a real person, not an impersonator. Here are a few tips to help you protect yourself and know what to expect from us: • Apply only through our official channels. All open roles are listed on our official careers page: careers.cookunity.com, • Our recruiters are real people — and easy to verify. You can always find them on LinkedIn with verified profiles. If you're unsure, feel free to reach out to us on our official LinkedIn Company Page., • We only communicate through official CookUnity channels. That means emails ending in @cookunity.com and interviews held through official company platforms (Google Meet or Zoom) — never WhatsApp, Telegram, or SMS.

Job Description WSAudiology is a global leader in the hearing aid industry. Together with our 12,000 colleagues in 130 countries, we invite you to help unlock human potential by bringing back hearing for millions of people around the world. Part of WSAudiology group, HearUSA is on a mission to reframe the world of hearing care and set the highest standard in modern hearing health. With an extensive network of 4,000 independent Hearing Care Professionals and more than 350 centers in U.S., we strive every day to provide each individual with the care, knowledge and experience they deserve. ESSENTIAL DUTIES AND RESPONSIBILITIES: • Perform comprehensive hearing evaluation, hearing aid selection and fitting for all clients, employing best practices as defined by our client-centric service model of Simply Excellent Hearing Care. Meets minimum NPS score of 75., • Routinely demonstrates hearing aids as part of annual evaluations for clients to experience the sound and create the ‘wow’ moment of a personalized auditory simulation., • Evaluate test results in conjunction with client needs' assessment to make a personalized recommendation. Offers recommendation based on maximizing client benefits., • Perform routine follow-ups, clean and checks and hearing aid repairs. Maintain skills in ear impression taking, earmold modification and recommendation of ALD accessories., • Embody HearUSA's ambition of Changing Lives through Simply Excellent Hearing Care. Partner with the District manager, HCP Team Leads and L&D to adopt new initiatives aimed to grow your Center's revenue and change more lives., • Build a local community to proactively generate service demand and support marketing campaigns, such as to physicians and at health fairs. Successfully completes one community outreach and/or physician marketing per quarter., • Comply with all State license laws, FDA guidelines, WSA policies and HearUSA Quality Practice Guidelines (QPG). Operates in a HIPAA compliant manner, with documentation, outcome notes and referrals completed for all clients., • Engage in Continued Professional Development to maintain expertise in all aspects of service delivery, from consultative counseling to the selling, fitting and troubleshooting of current hearing aid technology., • Embraces our culture and values of Going Beyond Together, Pioneering for Better Solutions, and Passion for Impact.REQUIREMENTS:, • Experience in a similar Audiology or Hearing Aid Specialist role., • Active state license in Audiology and/or hearing aid dispensing., • 1-5 years of experience preferred., • Ability to pay close attention to detail with a high degree of accuracy., • Basic or advanced written communication skills., • Experience interacting with customers/clients., • Ability to communicate detailed or technical information clearly, accurately and concisely., • A structure of field support for your hearing center, • A professional development team of dedicated Regional Training Managers, • Continuing education, LinkedIn Learning & licensing reimbursement, • Career advancement pathways such as Hearing Care Provider and Client Experience Specialist Team Lead, Hearing Care Provider Advisory Board member, or District Manager, • Monthly Commissions, • CEUs & State Licensure Renewals for HCPs, • Defined Career Paths, • Sponsorship & Preceptor Opportunities, • President’s Club Incentives, • Employee Referral Program LIFESTYLE & BENEFITS:, • Comprehensive Benefits Package, • Paid Holidays & PTO Policy, • 401k Matching Program, • Tuition Reimbursement, • Employee, Family & Friends Hearing Aid Discount Program The Company provides equal opportunity to all employees and prospective employees without regard to race, color, creed, religion, national origin, ancestry, sex, age, physical or mental disability, marital status, pregnancy, genetic information, sexual orientation, gender identity, protected veteran or military status, or any other consideration not related to the person’s ability to do the job or otherwise made unlawful by federal, state, or local law.

Job DescriptionABOUT PROJECT HEALTHY MINDS Project Healthy Minds is a mental health tech non-profit startup. We are pioneering a first-of-its-kind model: applying technology to address one of the biggest social issues of our time: the growing mental health crisis. We believe in a simple but profound idea: that it should be as easy to find mental health services as it is to book a flight or a restaurant reservation. That's why we're building the world’s first digital marketplace for finding mental health services that are right for you. To do that, we work with some of the most inspiring and influential leaders in America - business titans, tech entrepreneurs, clinicians and scientists, musicians, artists, athletes, media stars, policymakers, and more - because we believe that the world's most complex challenges require interdisciplinary teams and solutions. We are backed by a powerhouse of industry-leading Board of Directors and Advisory Council Members who are passionate, hands-on, and dive into the important work with us. Learn more at projecthealthyminds.com and @projecthealthyminds on social. ABOUT THE ROLE WHAT WE’RE LOOKING FOR: We’re hiring a Director of Special Events who will set and execute a category-redefining vision for Project Healthy Minds’ events slate and lead all fundraising events at Project Healthy Minds. This leader should have four superpowers: • An extraordinary level of creativity and experience conceptualizing and producing outside-the-box, elevated events.• The production chops to make a Coachella production manager blush – someone who intuitively understands production specs and labor needs, has a deep network of vendor relationships and knows how to negotiate and manage vendors, knows all of the different shapes of venue deals and just as importantly, knows how to work with venues, and has the leadership qualities to lead a multi-stakeholder process for signature events and ensure the production of our events is world-class.• Exquisite taste and editorial brilliance to curate the right topics, speakers, and participants to ensure Project Healthy Minds events are some of the most intellectually interesting events around.• An unmatched strategic, fundraising mindset to ensure that all of our events inspire individual donors and corporate partners to philanthropically support the mission of the non-profit. This role will report into the VP of Development, will work very closely with the Founder & CEO, and will serve as a leader working cross-functionally with other members of the Development and Creative teams to conceive and execute groundbreaking events. HOW YOU’LL CONTRIBUTE:• Set the strategic vision and roadmap for the Project Healthy Minds fundraising events strategy – from culture-driven fundraisers (e.g. our annual gala) to intimate, VIP events.• Lead the strategy for each Project Healthy Minds fundraising event – setting the programming, editorial, and talent vision, shaping the creative direction (with the Head of Creative), developing the fundraising strategy, creating the production and staffing plans, etc. • Drive the execution of all event production elements end-to-end in a hands-on manner – providing strong day-to-day leadership to all internal stakeholders, external vendors, and venue partners. • Lead all vendor and venue relations – from sourcing to negotiation to management to reporting.• Quarterback the process for securing talent for all events – working in close partnership with the CEO, the VP of Development, Board of Directors, internal staff, and other key VIP partners/friends to Project Healthy Minds.• Create detailed end-to-end planning timelines for events and run the process to ensure best-in-class execution across the team.• Own the P&L for all events.• Oversee the creation of all event materials (e.g. digital experiences, solicitation materials, printed materials at the event, etc.) – working in close partnership with the Creative and Development teams.• Ensure a world-class guest experience, thoughtfully considering the end-to-end user journey across every Project Healthy Minds touchpoint (pre-event, day-of, post-event).• Partner with the rest of the development staff to create thoughtfully curated invite lists and initiation strategies.• Manage partners and stakeholders.• Provide robust reporting to various stakeholders throughout the event planning and recap cycle. ABOUT YOU OUR IDEAL CANDIDATE IS:• A true event production pro – you have a proven track record with all aspects of events – from conceptualizing the programming structure and flow to setting timelines and driving planning processes to coordinating all production aspects (audio, video, labor, staging, catering, etc.) to leading the negotiation and management of labor/production needs to sourcing and managing vendors to creating detailed run-of-shows and so much more.• Detail-oriented and the most organized person in the room – you love developing effective systems. You are a meticulous planner and can ensure that all the moving parts of an event are clear and categorized. You keep the trains on the track and ensure all stakeholders meet deadlines.• Accomplished in the development/fundraising space – you understand the nuance required to produce world-class events that achieve strategic development objectives, you understand the non-profit and elevated VIP event landscapes, and you know how to work with internal development teams and external stakeholders.• A leader who enjoys building something new – you thrive in a fast-paced environment and identify as a multitasker that can perform under pressure. You enjoy leading cross-functional teams and being the leader that everyone looks to for vision, decisions, and timely feedback. You respond skillfully to rapidly changing priorities and are excited by the prospect of every day being different with new problems to solve. You are willing to travel for this role if needed.• A strong communicator – you have exceptional oral and written communication skills with an ability to engage and inspire a wide range of audiences and a diverse team of stakeholders. • Experienced – Bachelor’s degree and 15-20+ years of experience running events with proven success, ideally in the nonprofit space. WHAT WE OFFER

Job DescriptionJob Title: Product Compliance Manager (Full Time) Position Summary: Sound Around is committed to delivering high quality innovative products that drive customer satisfaction and business growth. We are seeking a Product Compliance Manager to lead our quality assurance and compliance programs and ensure our products meet industry standards and exceed customer expectations. The Company For over 45 years, Sound Around, a family-owned enterprise headquartered in Brooklyn, New York, has been a leader in the consumer products industry. Our diverse range of brands, including Pyle, Lanzar, Serene Life, Pyramid, Nutrichef, and American Legacy, are prominently featured through leading online retailers. As a rapidly growing multimillion-dollar family business, we specialize in branding products for e-commerce channels. We are seeking highly skilled professionals who can contribute to our ongoing success while embracing the unique dynamics of our family business structure. Core Values Our core values guide everything we do: 1. Amplify Positivity: Embrace a positive approach in every interaction. Find opportunities within challenges, pivot when necessary, and radiate enthusiasm to cultivate a We Can Do This! culture., 4. Share Generously: We foster a culture of collaboration by actively sharing ideas, thoughts, and credit for success. Our willingness to help others succeed enriches our collective achievements Responsibilities:  Quality Assurance Product Performance: Develop and manage QA/QC programs, pre-purchase (PPT) and post-purchase (PoPT) testing, and inspection protocols to enhance product quality and customer satisfaction.  Regulatory Compliance: Monitor industry regulations (CPSC, FDA, EU Commission, ASTM, ISO), assess impacts on processes, and implement necessary changes.  Consumer Feedback Risk Mitigation: Analyze customer feedback, returns, and adverse events to identify and address quality issues. Lead product risk assessments and corrective action plans.  Supplier & Vendor Management: Conduct supplier quality audits, develop training programs, and ensure adherence to compliance standards.  Continuous Improvement: Identify opportunities to improve product performance, reduce defect rates, and drive consumer loyalty.  Recall & Incident Management: Evolve protocols for possible product recalls, ensuring swiftaction and regulatory compliance.  E-commerce Compliance: Manage marketplace listings, addressing non-compliant or underperforming products effectively. Key Metrics for Success:  Improved product ratings and consumer satisfaction  Reduced return rates and defect incidents  Enhanced supplier compliance and performance  Increased sales and profitability of monitored products Qualifications & Skills:  Strong understanding of consumer protection laws, compliance regulations, and retail industry standards  Proven experience in compliance, quality assurance, or product management in a retail or e- commerce setting  Excellent analytical and problem-solving skills  Effective communication and stakeholder management abilities  Ability to manage complex projects independently and collaboratively  If you are passionate about driving product excellence and compliance in a fast-paced environment, we’d love to hear from you! Apply today. Compensation & Benefits  $100-125k + 10% bonus  Paid Time Off  Benefits: Individual health insurance and 401k  Location: Brooklyn, NY Powered by JazzHR v1gduzAq35

Job Description Job Title : Regulatory Support Location: Basking Ridge NJ Remote Option: Yes. But the candidate should be available to attend customer meetings twice in a month Requirements Mandatory skills: -experience in pharmaceutical environment. -Experience in regulatory environment is required. -High level exposure or knowledge about FDA inspection and internal audit process. -Knowledge or exposure on Veeva RIM Submission/Archive, Publishing etc. Job Title: Consultant JD details : -Ensure compliance with company Standard Operating Procedures and regulatory agency regulations/guidance. -Represents Regulatory Affairs on cross-functional project teams. -Provide technical expertise to cross-functional teams on managing the lifecycle of submission-related documents. -Work with subject matter experts, and cross functional departments to support business needs. -Effectively communicate and work collaboratively with cross-functional teams, including regulatory affairs, clinical operations, and quality assurance & validation. -Gather and assemble information necessary for submissions in accordance with regulations/guidance. -Capable of reviewing documentation with a high degree of attention to detail. Proactive to identify issues and propose solutions, as necessary. -Conduct review of published submissions to ensure consistency and compliance with regulatory requirements. -Maintain knowledge of local and global regulatory submission requirements. -Maintain compliance with GxP, government regulations, industry standards, approved specifications, and Company procedures &directives. -Provide Regulatory Affairs support during internal and external audits and inspections. -Exposure in Change management process, requirement gathering, qualifying the changes etc., -Actively participate in the development of Regulatory Operations processes like SOPs/GOPs, Work instructions, Checklist, templates etc. -Consistently support for regulatory systems access and change management. -Responsible for communicating business process improvements, business related issues, status updates or opportunities. Qualifications: -Bachelors’ degree, preferably in a life science or a related field -5 to 10 years of experience in pharmaceutical environment. -Experience in regulatory environment is required. -Excellent written, verbal communication and presentation skills. -High level exposure or knowledge about FDA inspection and internal audit process.