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• Paris Baguette

  

  Director of Architecture & Design

  1 day ago

  $140000–$150000 yearly

  Full-time

  Moonachie

  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 The Director of Architecture & Design is responsible for leading Paris Baguette's architectural vision and design standards across all new café openings, refreshes, and remodels in the United States and internationally. This role owns the full design lifecycle — from prototype development and test-fit review through construction document approval and project closeout — and serves as the primary steward of brand design integrity across the entire café portfolio. The Director will build and manage a high-performing external architecture network, drive continuous improvement of design standards and prototype efficiency, and partner cross-functionally with Construction, Real Estate, Operations, and Marketing to ensure every café reflects the Paris Baguette brand at its best. KNOWLEDGE AND RESPONSIBILITIES Design Leadership & Standards • Own and continuously evolve Paris Baguette's prototype design, brand standards, and design guidelines across all café formats (inline, endcap, freestanding, non-traditional)., • Review and approve all test-fit layouts for new locations, ensuring compliance with prototype standards, operational requirements, and brand criteria., • Lead comprehensive review and redline of construction document (CD) sets, identifying design deficiencies, code conflicts, and brand deviations prior to permit submission., • Approve all design elements — materials, finishes, millwork, signage, lighting, furniture, and equipment placement — for new builds, refreshes, and remodels., • Develop and maintain a design element library and approved vendor/product specifications to ensure consistency and procurement efficiency across the portfolio. Refresh & Remodel Program • Lead the design and coordination of the café refresh and remodel program, including scope definition, phasing strategy, and budget benchmarking., • Partner with Operations and Franchise Business Consultants to prioritize refresh candidates and develop refresh tiers aligned to investment levels., • Ensure remodel designs balance brand elevation with operational continuity, minimizing franchisee disruption and downtime. External Architecture Network • Build, manage, and evaluate a national network of preferred architecture firms, ensuring geographic coverage, capacity, and performance standards are maintained., • Establish scopes of work, fee structures, and deliverable expectations for all external architect engagements., • Conduct ongoing performance reviews of architecture partners; onboard and offboard vendors as portfolio needs evolve., • Serve as the primary escalation point for design disputes, RFI resolution, and scope clarifications between architects, general contractors, and franchisees. Cross-Functional Collaboration & Process • Partner with Real Estate to evaluate site feasibility and inform LOI decisions based on design and construction viability., • Collaborate with Construction Project Managers throughout the project lifecycle to ensure design intent is preserved through permit and field execution., • Coordinate with Marketing and Brand teams to ensure café environments align with evolving brand positioning and campaign direction., • Interface directly with franchisees and their representatives to communicate design requirements, manage expectations, and resolve design-related issues., • Maintain and improve internal design review processes, approval workflows, and documentation standards to support a high-volume, fast-growing pipeline. Reporting & Administration • Track design review timelines and approval status across the active pipeline; report on bottlenecks, delays, and design-related risks to the VP of Development., • Manage the Architecture & Design department budget, including external architect fees, prototype development costs, and design tool subscriptions., • Stay current with trends in retail, QSR, and hospitality design; proactively recommend prototype updates and design innovations that enhance the guest experience and operational performance, • Other duties may be assigned WHAT YOU NEED TO HAVE • Bachelor's degree in Architecture, Interior Design, or related field required; Master's degree preferred. Licensed Architect (AIA) strongly preferred., • At least 10+ years of progressive experience in architecture and design, with a minimum of 5 years in a leadership role overseeing multi-unit retail, QSR, hospitality, or food & beverage rollout programs., • Demonstrated experience managing external architecture firms at scale across a national or multi-regional portfolio of 50+ concurrent projects., • Deep fluency in construction documents, redlining, and CD review processes; ability to identify code, coordination, and brand compliance issues across full CD sets., • Proven track record leading refresh and remodel programs from concept through execution., • Experience with franchise development environments and the ability to navigate franchisee relationships with professionalism and diplomacy., • Proficiency in AutoCAD, Revit, and/or BIM tools; working knowledge of project management platforms (e.g., Procore, Smartsheet, or equivalent)., • Exceptional organizational skills with the ability to manage a high-volume pipeline across multiple geographies simultaneously.Strong communication and presentation skills; comfortable presenting design direction and program updates to senior leadership and ownership groups. * Passion for brand, design quality, and the guest experience — with the operational mindset to balance design aspiration with build efficiency and franchisee investment.Ability and willingness to travel nationally to café sites, architecture firms, and franchise markets as needed., • Feedback is a gift! Ability to provide constructive feedback and recognition to every member of the organization, to ensure we have an open and transparent culture of high-performance standards., • High emotional intelligence and the ability to work collaboratively across diverse teams., • Passionate about empowering and developing others while upholding brand standards., • Teams Win! Must be a team player who fosters a collaborative and engaged teamwork environment., • Being a Brand Ambassador, with an excellent knowledge of and commitment to Paris Baguette's Mission, Vision, Brand Values and Culture. SWEET BENEFITS • Competitive compensation, • Free Cake for your Birthday, • Medical, Dental, Vision benefits, • 401K Retirement Plan, • Paid time off, paid Holidays, • High Performance Culture

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• Paris Baguette

  

  National Distribution Manager

  2 days ago

  $80000–$90000 yearly

  Full-time

  Moonachie

  Reports to: Director of Distribution 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 The National Distribution Manager is responsible for overseeing end-to-end distribution operations ensuring timely, cost-effective, and compliant movement of goods from manufacturing and co-packing facilities to customers, distribution centers, and Franchise partners. This role leads to distribution strategy, 3PL management, and continuous improvement initiatives while maintaining the highest standards of food safety, quality, and service. The role partners cross-functionally with Procurement, Manufacturing, Quality, and Finance to support service level targets, cost controls, and growth initiatives. KNOWLEDGE AND RESPONSIBILITIES Freight & Transportation Management • Lead all inbound and outbound transportation activities, including TL, LTL, drayage, and refrigerated freight, • Manage relationships with 3PLs, carriers, and freight brokers, • Negotiate carrier contracts, rates, and service-level agreements to meet cost and service objectives, • Monitor freight spending, lane performance, accessorial, and carrier compliance, • Develop contingency plans for capacity constraints, weather disruptions, and peak seasons, • Collaborate with transportation and logistics teams to optimize outbound and inter-facility shipments, • Support distribution network design, including DC footprint, capacity planning, and lane optimization, • Identify cost-reduction opportunities while maintaining service and product integrity Food Safety, Quality & Compliance • Ensure compliance with FDA, USDA, and customer requirements, • Maintain cold-chain integrity and temperature control standards throughout transportation and storage, • Lead root cause analysis for freight-related quality issues and corrective actions Cost Control & Continuous Improvement • Assist with transportation and distribution budgets, forecasts, and KPIs, • Drive continuous improvement initiatives to reduce freight costs, damages, and lead times, • Implement routing guides, mode optimization, and network design improvements, • Track and report metrics such as freight cost and damage rates Systems & Analytics • Lead the use and optimization of TMS, WMS, ERP, and freight audit/payment systems, • Analyze data to identify trends, risks, and opportunities for improvement, • Support system implementations, integrations, and upgrades Leadership & Cross-Functional Collaboration • Support and develop a team of logistics and distribution professionals, • Establish performance goals, coaching, and succession planning, • Partner with Quality Control, Operations and Finance to support customer requirements and margin goals, • Act as escalation point for service failures and customer-impacting issues, • Other duties, as assigned. WHAT YOU NEED TO HAVE • Bachelor's degree in supply chain, or related field, • At least 5+ years of progressive experience in frozen food distribution or cold-chain logistics, • At least 5+ years managing multi-site, multi-region distribution operations, • Deep knowledge of frozen cold-chain requirements and global food safety regulations, • Experience with global trade compliance and customs processes, • Advanced WMS and ERP experience (SAP, Oracle, Manhattan, Blue Yonder, NetSuite), • International logistics and trade compliance, • Operational excellence on a scale, • Financial and cost-to-serve optimization, • Strong people leadership across cultures, • Risk management and resilience planning, • Regular presence in frozen warehouse environments (freezer conditions), • Feedback is a gift! Ability to provide constructive feedback and recognition to every member of the organization, along with Franchisees, to ensure we have an open and transparent culture of high performance standards., • High emotional intelligence with the ability to work with, and support 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 team work environment., • Being a Brand Ambassador, with an excellent knowledge of and commitment to Paris Baguette's Mission, Vision, Brand Values and Culture. SWEET BENEFITS • Competitive compensation, • Free Cake for your Birthday, • Medical, Dental, Vision benefits, • 401K Retirement Plan, • Paid time off, paid Holidays, • High Performance Culture

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• Catholic Charities of the Archdiocese of Newark

  

  Case Manager - Full Time

  30 days ago

  Saddle Brook

  Job DescriptionCatholic Charities of the Archdiocese of Newark is one of New Jersey’s largest non-profit social service agencies with programs and facilities serving Bergen, Essex, Hudson, and Union counties. We are currently seeking a Full-Time Case Manager for our Upper Saddle River program in Upper Saddle River, NJ. Job Duties: • Asses clients' needs, • Development and implement service plans for clients, • Provide referrals when required, • Responsible for continuity of care and ensuring that appropriate quality services are provided Requirements: • Bachelor’s Degree, • 1 year of related experience in social services, • Valid NJ driver's license, • Bilingual preferred Visit our website www.ccannj.com Internal Applicants: Please be advised that current employees applying to open positions within the Agency are required to fill out an Agency Internal Job Application Form which is available for download to all employees on HR's public folders in Outlook. Please forward the completed form to HR via email to the agency email address indicated. Agency Mission: In response to the Gospel of Jesus Christ, Catholic Charities, as a ministry of the Archdiocese of Newark, serves the poor and marginalized and advocates for their needs in order to promote the inherent dignity and worth of all people without regard to race, religion, or culture. Benefits: CCAN offers a competitive compensation and comprehensive benefits package for employees, with an 80/20% cost split between employers (80) and employees (20). CCAN is an equal opportunity employer. M/F/D/V. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex, sexual orientation, gender identity, gender expression, national origin/ancestry, citizenship status, disability, age, marital or family status, and military or veteran status. Potential Eligibility for federal student loan forgiveness Rate: $18/hr Powered by JazzHR lzEAJUul2H

• SpecialtyCare

  

  Registered Nurse (RN) - ECMO Coordinator

  27 days ago

  Saddle Brook

  \n SpecialtyCare is seeking a Registered Nurse (RN) ECMO Coordinator for a nursing job in Saddle Brook, New Jersey. Job Description & Requirements\n \n • Specialty: ECMO Coordinator\n, • Discipline: RN\n, • Duration: Ongoing\n, • 36 hours per week\n, • Shift: 12 hours\n, • Employment Type: Staff\n \n As an ECMO (Extracorporeal Membrane Oxygenation) Specialist you will operate and maintain ECMO circuits for patients requiring long-term pulmonary and/or cardiopulmonary support. The ECMO Specialist functions interdependently following standing ECMO orders and parameters under the direction and clinical supervision by of an ECMO physician. \n Duties and Responsibilities: \n Assist the physician, perfusionist and/or other clinical staff members with initiation of ECMO, the course and conduct of ECMO, and the conclusion of ECMO and any related therapies therein including but not limited to circuit or component changes, priming, blood bank communications, medication administration as licensure permits, and hemofiltration as examples. \n Demonstrate a culture of safety through a hand-off of the ECMO patient covering all aspects of the patient’s care and the state of the ECMO circuit. \n Provide a detailed examination of the circuit to ensure its integrity, while written parameters and a plan of care are worked out during rounds. \n Ensure the continuity of the ECMO circuit as a whole, keeping it safe and secure during patient handling. Reducing the risks of circuit compromise by regular assessments is ongoing. \n Assess blood gas values, anticoagulation parameters and other laboratory values and work within a prescribed set of parameters and guidelines to maintain the patient in an optimal state of well-being. \n Monitor anticoagulation, analgesics, inotropes and other infusions are titrated, blood products are ordered and given, and the ECMO pump flow and oxygenator gas flow adjusted as needed. \n Lives the SpecialtyCare Values- Integrity, Care, Urgency, and Improvement. \n Qualifications: \n Must possess one of the following education backgrounds, credentials and experience as an ECMO Specialist: \n Registered Nurse (RN) – holds either an Associate’s or Bachelor’s Degree in Nursing from an accredited education program. Has an active RN license to practice. \n Respiratory Therapist (RT)– holds either an Associate’s or Bachelor’s Degree in Respiratory Therapy from an accredited education program and current Registered Respiratory Therapist (RRT) certification. \n Bachelor’s Degree in Perfusion and a certification from American Board of Cardiovascular Perfusion or meets other Company requirements as a Perfusionist (CCP). \n Demonstrates a superior working knowledge of ECMO therapy including but not limited to the ECMO circuit and pump, adjustments to pump flow, sweep flow, FiDO2, anticoagulation therapy to maintain parameters within limits set by the physician, point of care testing, patient monitoring systems, and related policies and procedure guidelines. \n Benefits \n SpecialtyCare is committed to supporting professional growth for our associates. Each associate is allocated funds for continuing education, membership fees, and dues for professional associations. We also provide tuition reimbursement or tuition repayment assistance. We provide a full benefits package including a matching 401K and generous PTO plan. We also cover the cost of maintaining certification and licensure. \n SpecialtyCare is an Equal Opportunity and Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. \n SpecialtyCare Job ID #7015. Posted job title: RN ECMO Coordinator About SpecialtyCare\n \n Start Your Journey with SpecialtyCare \n \n Our versatile experts assist in a broad range of surgeries in ORs across the country, but one of the constants we see is the deep responsibility physicians feel for their procedures’ success and their patients’ health. \n Surgeons invest so much of themselves in their work, that it is only right they have a highly trained, capable, and trustworthy team by their side. \n Surgeons need integrated specialists who fully understand their methods and preferences. They need equipment that is perfectly prepped and ready every single time. They need people in the room pushing themselves just as hard as they are to deliver excellence day in and day out. That’s why we work with and train the best in perfusion, IONM, ECMO, surgical assist, minimally invasive surgical support, deep brain stimulation, and more. Discover rewarding roles in allied healthcare that offer growth, development, and the chance to positively impact lives every day. \n Benefits\n \n • Continuing Education\n, • Employee assistance programs\n, • Vision benefits\n, • Discount program\n, • 401k retirement plan\n, • Sick pay\n, • Medical benefits\n, • License and certification reimbursement\n, • Mileage reimbursement\n, • Dental benefits\n, • Life insurance\n \n

• Health And Wellness Partners

  

  Product Manager

  2 days ago

  Saddle Brook

  Job Description Why Join the HWP Group? Health & Wellness Partners, LLC (HWP), is a medical and scientific communications agency that collaborates with life science industry stakeholders to develop award-winning solutions that advance patient care and transforms scientific content into compelling live and virtual user experiences through digital platforms, congress engagement, and more. We bring clients, providers, and patients outstanding educational programming paired with innovative digital and interactive dissemination vehicles. We are committed to making a difference in health care and in the lives of our team members. We aim to provide every employee with a job they love in a culture focused on career growth, well-being, and community outreach. We have been recognized as both an MM+M Best Place to Work and an Inc. Best Workplace. For more information, visit thehwpgroup.com. What You Need to Know We’re looking to add a Product Manager to the Product Management team. The Product Manager is responsible for managing day-to-day execution and ensuring alignment among technical teams, stakeholders, and product requirements. This role will manage software product development projects executed by Application Developers and communicate status and completion with internal and external Clients. The key focus of this role is delivery and stakeholder engagement. What You’ll Do • Lead weekly production meetings with assigned clients, facilitating discussions, capturing business requirements, documenting decisions, and driving action-item follow-through to ensure alignment across stakeholders, • Deliver software demonstrations, training sessions, and feature presentations to clients and internal stakeholders, promoting product adoption and user proficiency, • Evaluate product enhancement requests, define requirements, and develop comprehensive execution plans that align business objectives with technical capabilities, • Conduct independent quality assurance testing of Speaker Bureau platform enhancements, validating functionality against client requirements, • Proactively identify risks, dependencies, and potential obstacles impacting client deliverables, and develop effective mitigation strategies to maintain project success, • Document software defects, edge cases, and unexpected system behaviors; collaborate closely with the Development Operations teams to prioritize resolution and lead retesting to confirm fixes meet acceptance criteria, • Serve as the primary liaison between clients, business stakeholders, and Development Operations teams, translating business needs into technical requirements and ensuring clear, consistent communication throughout the development lifecycle What You’ll Have • 2+ years of Product Management or other relevant experience, • A degree with a major in a technology field, • Med com experience is a plus, • Proficiency in software configuration and troubleshooting, with the ability to diagnose issues and guide effective resolutions., • Knowledge of Microsoft® Word, Excel, PowerPoint, and Access, • Ability to lead and prioritize multiple initiatives, managing competing deadlines in a fast-paced environment, • Detail-oriented with accountability for accuracy, quality, and compliance across deliverables, • Collaborative partner working effectively with cross-functional teams to drive outcomes, • Capable of identifying challenges and implementing effective solutions quickly, • Exceptional verbal and written communication skills, • Commitment to ensuring customer satisfaction and building positive relationships What We Offer • Immediate eligibility for all benefits, including medical, dental, vision, group term life, short-term and long-term disability, • Benefits 100% company paid, • 401k plan employer matching contributions, • Eligibility for company-sponsored incentive plans, • Generous PTO, including a week off in December for the holidays, • Paid volunteer time off, • Tuition reimbursement, • On-site gym and other employee wellness initiatives, • Employee Assistance Program, • Comp pay or comp time for onsite weekend work, • Availability of cell-phone stipends, based on business need, • Leadership development training program and other career development programs, • Remote and hybrid work schedule options, • Office locations in Upper Saddle River NJ (HQ), Red Bank NJ, and San Diego CA, • Salary range: $68,000 – $80,000 annually. Note: Actual salary will depend on background and experience. M/F/D/V Please note, we will only respond to candidates we deem qualified

• Lynkx Staffing LLC

  

  Manager Manufacturing Operations

  20 days ago

  Saddle Brook

  Job DescriptionManager Manufacturing OperationsAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Primary Processing Unit (PPU), Manager, Manufacturing Operations is responsible for efficient capacity utilization of site resources to meet customer demand. They will partner with support functions to deliver on customer demands. This leader is accountable for the management of client projects at the site and for delivery of results within project scope, agreed timelines, contract requirements, revenue targets, as well as compliance and regulatory requirements. The Manager, Manufacturing Operations is responsible for profit and loss within their PPU and will deliver on revenue. This role will also drive individual and team development to ensure a prepared and empowered workforce to become the provider of choice for the industry. • Meet client process demands through planning, scheduling, manufacture and delivery., • of clinical cell therapy products according to established procedures, regulations and contract., • Ensures manufacturing documentation is closed out in a timely manner in accordance with applicable regulations and per contract., • Ensures capacity availability of resources (room/equipment/staff) to perform clinical manufacture for clients per contract., • Ensures process hours are charged - tracked to meet contract and revenue targets., • Accountable for maintaining a mechanism to work with clients to troubleshoot problems, suggests improvements and determines & advocates for value-add projects., • Assures manufacturing space is kept in a clean, validated state in compliance with company procedures, GMP and applicable regulations, • Ensures on the job training program and resources for new associate (proficiency) training and cross training of existing staff., • Ensures a safe work environment for employees., • Ensures department staff compliance with corporate and site-specific HR policies, safety and business policies and practice., • Approves job specific curriculum for the training and professional development of department staff., • Holds regular staff and 1:1 meetings to emphasize corporate culture, maintain morale, and provides a forum for staff development and discussion., • Responsible for the profit and loss for the PPU, • Deliver on revenue, • Assures compliance with budget, • Liaison with support groups – supply chain, training, quality systems, and business development, • Partners with clients along with Project Management and team leadership; drives the account management and liaison with the clients, • Sets team expectations and goals and delivers the business direction for the PPU, • Sets KPIs & ROIs targets and assures PPU metrics are maintained and tracked monthly., • Coordinates with PPU leadership and team meetings and determines PPU strategy development, • Accountable for driving the spirit of continuous improvement, • Collaborates with Business Development to ensure compliance and contract requirements, • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Directly supervises the following roles: Associate Manager, Manufacturing, Manufacturing Associates, Lead Manufacturing Associates, Production Support Associates, Technical Trainers, Compliance InvestigatorsREQUIREMENTS, • Bachelor's degree (ie Biology, Biotechnology, Bioengineering, Chemical Engineering)., • 5-7 years of cGMP environment, aseptic processing, mammalian cell culture, cell processing, cryopreservation experience., • 5-7 years of leadership experience or equivalent combination of experience., • Strong business acumen, • Deep understanding of cGMP and cGLP, • Working knowledge of financial operations and budget development, • Relevant IT skills (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, • Meeting management/facilitation skills/teamwork, • Ability to multi-task team is essential, • Flexible and able to adapt to company growth and evolving responsibilities, • Drive to create and maintain order in a fluid technically complex environment, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • List required training that must be completed by incumbent in order to fulfill the responsibilities for this role. Examples can include aseptic techniques, gowning qualifications, manager training, GMP, etc., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the company, • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen, • Must have the ability to work in the cleanroom environment for extended period of time, • Must have the ability to work with specialized equipment, • May work with hazardous materials and chemicals, • Environment requires gowning, hair net, safety glasses, gloves, and foot coverings.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.

• Lynkx Staffing LLC

  

  Quality Control Manager

  6 days ago

  Saddle Brook

  Job DescriptionQuality Control Manager The Quality Control (QC) Manager plays a pivotal role in ensuring that QC is effectively serving in its support role to clinical and commercial production. The QC Manager will ensure that analytical testing for process check points, stability, and release assays are being carried out to certify that quality standards are upheld for all products produced at the facility. The goal is to ensure that the Quality Control group and company is constantly moving towards fulfilling its short-term and long-term objectives and does not diverge from its strategic guidelines. Under the direction of the VP, Global Quality Head, responsibilities of the QC Manager will include but are not limited to: • Leading, hiring, developing, training, and evaluating QC personnel, • Devising sound hiring strategies based on business needs, • Supervising and overseeing QC personnel in their roles for safe and efficient verification, approval, release/disposition of HCATS and/or client products/materials, • Delegating responsibilities and supervising the work of laboratory personnel, while providing guidance and motivation to drive maximum performance, • Ensuring and promoting compliance with applicable cGMP and GTP regulations, while ensuring compliance with company and client methodologies, • Assuring alignment and efficient continuity in laboratory practices between sites, • Serving as approver in investigations while overseeing timely closure of deviation reports, change controls, CAPAs, and applicable batch records, • Ensuring completion of all client QC requirements related to GMP cellular products and/or materials, • Overseeing QC role in material dispositions via deviation reporting system, CoAs, and/or client-based systems, if applicable, • Prioritizing, scheduling, and managing multiple projects and resources simultaneously, • Monitoring effectiveness of quality systems, change control activities and their completion, for both, internal and client audit findings, • Evaluating and investigating customer complaints and deviations; coordinating corrective and preventive actions as they relate to the Quality Control function, • Delegating maintenance, tracking, and trending aspects of the deviation reporting system, • Developing and maintaining Key Performance Indicators (KPIs) for laboratory testing, • Interfacing with vendors, suppliers, and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies, when applicable, • Interfacing with management at all levels for alignment on significant deviation resolution and corrective action implementation, • Delegating development, revisions, and implementation of Standard Operating Procedures as related to Quality Control activities, • Participating in and tracking group budget setting and cost containment drives, • Communicating and maintaining trust relationships with senior management, business partners, and clients, • Ensuring company policies and legal guidelines are communicated top-down in the company and that they are followed at all times, • Completing projects and special tasks as assigned by the Global Quality Head, • Off-schedule shifts during weekends and holidays based on business requirements a possibility, • On-call presence preferred while physical personal presence is not possible, • Candidate will oversee QC Scientist and QC Associate I, II, and III roles. The QC Manager will delegate responsibilities to direct reports to achieve the requisite business needs, while providing ongoing support to Manufacturing processes.REQUIREMENTS, • BA/BS/MS in a science or relevant field required, • Master’s in Business Administration or relevant field will be preferred, • 7 – 10 years’ experience in the pharmaceutical, biologics or related industry, • Prior cGMP experience required, • Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment a must, • Experience in Flow Cytometry is a must, • 5 + Years experience leading a team is a must. Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff, • Sound understanding of current Good Manufacturing Practices (cGMPs), • Working knowledge of routine QC laboratory procedures such as flow cytometry and CBC analysis, endotoxin testing, equipment and systems, and understanding of production processes and validation, • Prior experience with reviewing Standard Operating Procedures, work instructions, protocols, methods, method validations preferred, • Proven experience in a supervisory or managerial position, • Demonstrable experience in developing strategic plans based on business needs, • Strong understanding of Quality Control in pharmaceutical/biotechnology/biologics industries, • Thorough knowledge of market changes and forces that influence the company, • Proficient with computer software: Microsoft Office, Visio, • Strong written, oral, and presentational skills, • Strong knowledge of QC Analytical testing methodologies, philosophies, method validation and method transfers, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review, • Excellent organizational and leadership skills, • Excellent communication, interpersonal, and presentation skills, • Outstanding analytical and problem-solving abilities, • Strong business acumen, • Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner, • Candidate must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilitiesWhile 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. The noise level in the work environment is moderately noisy. Must have the ability to work in a team-oriented environment and with clientsMust be able to handle the standard/moderate noise of the manufacturing facility 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.

• Lynkx Staffing LLC

  

  Sr. Manager QA Validation Computerization Systems

  6 years ago

  Saddle Brook

  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.