Pharmaceutical compliance jobs in New York, New York - Page 5Crear alertas

Assist Chief Compliance Officer, North America (CCO), with the design, implementation, oversight, and enforcement of policies and practices to ensure corporate compliance with regulatory requirements relevant to pharmaceutical manufacturers in the United States and Canada. Maintain understanding of

A global pharmaceutical company is seeking a Senior Specialist in Global Regulatory Affairs to support regulatory activities related to new product registrations and lifecycle management. The role includes conducting projects, managing regulatory submissions, and ensuring compliance with regulations

Support compliance activities including audits, inspections, and labeling-related escalations and non-conformances/ph3Requirements/h3pBS degree (or higher) in life science/ppA minimum of 4 years of experience in the pharmaceutical industry is required/ppA minimum of 2 years of experience in product

Regulatory Compliance Oversight. Ensure compliance with serialization, track?and?trace, and DSCSA requirements. Advise leadership on regulatory trends, enforcement priorities, and compliance risks.

The Quality & Compliance Manager oversees quality assurance operations for JLL's facilities team and subcontractors within a cGMP bio-pharmaceutical manufacturing environment. This role ensures full compliance with contractual, procedural, and regulatory requirements while maintaining oversight of m

A leading pharmaceutical company is seeking a Senior Director, Field Medical Affairs to lead their COVID/Virology MSL team. This role involves driving strategic medical plans, fostering relationships with Key Opinion Leaders, and ensuring compliance in HCP interactions.

Job Description The Veterinary Technician assists the veterinarians with patient care and treatments, dental procedures, surgeries, immunizations, euthanasia as well as client education, marketing and inventory maintenance at North Haledon Veterinary Care. This position requires a working knowledge of pharmaceutical drugs, common diseases; their symptoms, means of transmission, treatment and prevention, and other basic preventative health care recommendations. This is an overview of the position and the job responsibilities listed do not encompass the entire position. PRIMARY JOB RESPONSIBILITIES • Obtain and record patient histories., • Collect specimens and perform routine laboratory procedures., • Dispense and administer medications, vaccines, serums and treatments as prescribed by veterinarians., • Administer and monitor anesthesia under the direction of a veterinarian., • Prepare patients, instruments and equipment for surgery., • Assure that monitoring and support equipment such as anesthetic machines, cardiac monitors, scopes and breathing apparatus are in good working condition., • Assist in diagnostic, medical and surgical procedures using a range of high-tech diagnostic equipment including electrocardiographic, radiographic and ultrasonographic equipment., • Communicate with and educate owners., • Maintain knowledge of preventative healthcare recommendations in order to answer client questions, provide education on vaccines, flea and heartworm products, and assist in marketing veterinary services from which their pet would benefit, such as a dental cleaning, senior wellness, spay and neuter and boarding., • Maintain inventory of pharmaceuticals, equipment and supplies., • Clean, maintain and sterilize instruments, equipment, and materials., • Work well with all team members and ensure that your actions support the hospital, the doctors, and the practice philosophy., • Perform other duties as assigned. CONTROLS OVER WORK The Veterinary Technician works under the direct supervision of the Office Manager and Veterinarians who will indicate general assignments, limitations and priorities. Recurring assignments are performed independently. Deviations or unfamiliar situations are referred to the supervisor. Completed work is reviewed for technical accuracy and compliance with established procedures. SKILLS AND KNOWLEDGE • Knowledge of principles and processes for providing client and personal services. This includes client needs assessment, meeting quality standards for services, and evaluation of client satisfaction., • Knowledge of commonly used veterinary terminology (e.g. terms of anatomy, physiology, diseases, tests, etc.) in order to accurately enter specific information into patient records. Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar. The physical demands described here are representative of those that must be met by an employee to successfully perform the primary functions of this job. • Frequently required to bend, stand, stoop, walk, sit, talk, and listen, frequently working in a bent position. Standing for greater than 8 hours., • Frequently use hands to manipulate, handle, or feel; will reach with hands and arms., • Use strength or agility in capturing and restraining stronger, more active animals., • Frequently lift and/or move up to 50 pounds. Occasionally handle dogs weighing up to and over 150 lbs. Assistance will be provided when working with larger animals. WORK ENVIRONMENT While performing the duties of this job, the employee is exposed to hazards associated with aggressive patients; hazards associated with infected animals and controlled substances; exposure to unpleasant odors and noises; exposure to bites, scratches and animal wastes; possible exposure to contagious diseases. Follow federal and state animal health laws and regulations including OSHA and DEA.

Job Description ABOUT ORGANOX: OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company’s first product, the OrganOx metra® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally. Position Summary The position of Manager QMS & Document Services is responsible for architecture of our Quality Management System and any and all infrastructure elements to affect an efficient and effective QMS and will further have responsibility to oversee, configure, continually improve our document management, change, and control processes. This role is critical to our ability to reflect our core values of customer first, be passionate, uphold respect and think boldy, and a commitment to transplantation. The Manager, QMS & Document Services will report directly to the Director, Quality Assurance. The Manager plays a key leadership role in building organizational capability leading, developing, and inspiring a global team; collaborating across functions; and embedding a culture of excellence in quality and compliance. Success in this role will be measured not only by the robustness of the QMS, but also by the strength, resilience, and effectiveness of the team delivering it. Listed below are the key responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally inclusive and may be augmented by leadership. This is a flexible, on-site role in our Madison, NJ office to ensure the ongoing Quality and Compliance of OrganOx Quality Management System. Major Responsibilities Under direction from the Director, Quality Assurance, the Manager QMS and Document Services will be responsible for: Leadership & Organizational Capability • Build, lead, and develop a high-performing global QMS and Document Services team, creating clear pathways for professional growth, capability development, and succession., • Foster a culture of collaboration, accountability, and continuous learning, aligned with OrganOx’s values of customer first, be passionate, uphold respect and think boldy., • Act as a visible quality leader across the business, engaging with senior stakeholders to align QMS and Document Services strategy with company objectives., • Drive organizational capability in document services by developing best practices, training programs, and cross-functional knowledge-sharing., • Partner with leaders across functions (R&D, Operations, Clinical, Regulatory, IT, etc.) to embed QMS ownership and accountability throughout the organization., • Lead the architecture, design, and continual improvement of the OrganOx QMS to ensure compliance with all applicable regulatory and quality standards., • Utilize Product Data Management best practice to ensure compliance with regulatory and quality standards., • Provide strategic oversight of document management, change control, and MasterControl-based processes, identifying innovative ways to streamline and strengthen compliance., • Define and manage resource requirements, ensuring the team is equipped to deliver against business and compliance needs., • Champion the use of quality metrics, ensuring data-driven insights inform decisions, continuous improvement, and reporting to leadership., • Act as a collaborative cross-functional partner, promoting consistent, high-quality practices across global sites., • Provide timely and evidence-based communication to the Executive Team, peers, and global colleagues., • Ensure effective budget management and resource allocation in collaboration with the Director, Quality Assurance and other stakeholders., • Proactively ensure compliance with all relevant international regulations, including US 21 CFR 820 (QMSR), EU MDR 2017/745, SOR 98-282, TGA MDR 2002, and ISO 13485., • Serve as a key contact point during internal and external audits, providing leadership presence and demonstrating system excellence. Skills & Experience • A demonstrated record of success in Quality Management System oversight as demonstrated by successful regulatory audits and inspections., • An expert-level knowledge of Software-based Quality Management Systems., • An expert-level knowledge of Document Control and Change Management., • Demonstrated proficiency in leading and developing successful transaction-based teams., • Demonstrated ability to lead organization-wide change initiatives and management., • High level interpersonal skills to both lead a team and to influence the wider organization. Qualifications • Minimum of a bachelor’s degree in a Life Science, Engineering or Technical subject., • A minimum of 4 years of document control and change management experience in the Medical Device, Pharmaceutical or other regulated industry is essential., • Experience in eQMS systems such as MasterControl, TrackWise, Windchill or others is required., • Experience in effective budget management and resource allocation is highly preferred., • Strong knowledge of medical device standards and regulations such as: US 21 CFR 820 (QMSR), EU MDR 2017/745, SOR 98-282, TGA MDR 2002, and ISO 13485; Knowledge of other relevant regulations and upcoming changes would be advantageous., • Must have at least one year of experience managing direct report(s)., • Ability to travel internationally up to 10% annually. #LI-Hybrid A job description does not imply that the duties stated are the only ones to be performed by the job holder. Job holder will be required to follow any other job-related instruction as reasonably requested by their line manager or their designate. Benefits The Pay Range for this position is $140,000 - $150,000 annually, with a 20% target annual bonus and benefits. We offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts. Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility. OrganOx supports work-life balance and provides opportunities for ongoing professional development. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.