- Legend Biotech USA, Inc. (Raritan, NJ)
- …people management and leadership experience is required.Experience working with quality systems is required.Extensive knowledge of chemical, biochemical ... treatment of multiple myeloma.Legend Biotech is seeking Head of Compliance as part of the Global Quality ...the supplier qualification program, including management of the electronic systems for this program.Work with External Quality … more
- Merck & Co. (Durham, NC)
- …Influence, Leadership, Networking and Partnerships, Program Management, Quality Management Systems (QMS), Quality Strategy, Regulatory Compliance , Risk ... Job DescriptionWe're looking for a Director of Quality Assurance to lead...advise, problem-solve, and drive continuous improvementImplement and oversee fit-for-purpose Quality Management Systems and standard ways of… more
- Merck & Co. (Ames, IA)
- …and Supplier ManagementThe Director will report to the Animal Health Global Quality Lead for Compliance and Technical Support and will direct the below ... aspects of the Supplier Quality Management (SQM) and Animal Health global auditing program:ResponsibilitiesPerform comprehensive and detailed GMP compliance … more
- Merck & Co. (Rahway, NJ)
- …into the Executive Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of Excellence ... compliant supply of commercialized products for the benefit of patients. The Director of Packaging Distribution, Components and Systems COE is integral… more
- Merck & Co. (Rahway, NJ)
- …Machine Learning (ML), Manufacturing Processes, Mechanical Testing, Medical Device Quality Systems , Medical Device Regulations, Medical Devices, Medical ... Process Manufacturing, Product Design, Production Process Development, Project Management, Quality Management Systems (QMS) {+ 4 more}Preferred Skills:… more
- Novo Nordisk Inc. (Boulder, CO)
- … Assurance (QA) function and serves as the leading expert in quality , compliance , and quality management systems (QMS). Provide direction & coordinate ... through testing and quality programs to ensure product safety and quality Responsible for ensuring compliance with all regulatory requirements and… more
- Repligen (Waltham, MA)
- …drives progress. Join us!About the RoleRepligen is seeking a hands-on, strategic Director of IT & OT Infrastructure to lead the design, implementation, and ... strategy, while overseeing internal teams, MSPs, and vendors to ensure high- quality , secure, and reliable services.You will lead and develop a high-performing… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director , Value & Implementation (V&I) Outcomes Research, position resides in the V&I organization, which includes Global Medical and ... payers, policymakers, health technology assessment (HTA)/ reimbursement agencies, and health systems globally. The ability to successfully participate in and lead… more
- Insmed Incorporated (NJ)
- …supporting biologics, drug products, or combination products.Deep knowledge of phase-appropriate quality systems , regulatory requirements (21 CFR Parts 210/211, ... from toxicology through Phase 3. This role ensures phase-appropriate GMP compliance across manufacturing development, while providing strategic Quality … more
- Merck & Co. (Rahway, NJ)
- …design verification testing, and process validation, with a strong understanding of quality management systems and regulatory compliance .Exceptional project ... sustained launch in alignment with the company's business goals, and quality and regulatory compliance .Essential Duties and Responsibilities:Program Leadership… more
- Insmed Incorporated (NJ)
- …structures consistent with NIST and FDA data protection standards.Partner with Legal, Compliance , Clinical Operations, Quality and R&D to proactively manage risk ... EU GMP Annex 11, and GAMP 5 guidelines a plus .Experience collaborating with Quality , IT, and business stakeholders to ensure systems are validated and remain… more
- Merck & Co. (Rahway, NJ)
- …Manufacturing Processes, Mechanical Engineering, Mechanical Testing, Medical Device Quality Systems , Microscopies, Negotiation, Optical Microscopy, Product ... Commercialization, Production Process Development, Project Management, Prototyping, Quality Management Systems (QMS), Self Motivation {+ 3 more}Preferred Skills:… more
- Insmed Incorporated (NJ)
- …Medical Excellence, Clinical Development, and Commercial Effectiveness to deliver high quality , strategic training plans. Partner with legal/ compliance to ensure ... environment across multiple international markets.Strong understanding of regional healthcare systems and compliance environments.Excellent presentation and facilitation… more
- Insmed Incorporated (NJ)
- …Communications, Field Medical Excellence, and Commercial Effectiveness to deliver high quality , strategic training plans. Partner with legal/ compliance to ensure ... environment across multiple international markets.Strong understanding of regional healthcare systems and compliance environments.Excellent presentation and facilitation… more
- Tris Pharma (Monmouth Junction, NJ)
- …strategies and operations, contract negotiations, supplier relationship management, procurement systems functionality/workflows and assurance of compliance with ... systems to maintain optimal stock levels and minimize obsolescence; Ensures compliance with safety, quality , and regulatory standards in warehouse… more
- Merck & Co. (Rahway, NJ)
- …Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE, the ... products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …s culture of excellence and compliance and working toward building a quality mindset with Medical Affairs.Support the Sr. Director 's Medical Affairs ... across all Medical Affairs programs. This role involves deputizing for the Sr. Director , representing the Quality organization at senior levels. The Director… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate Director , Logistics and Distribution Technology will be ... products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep… more
- Merck & Co. (Rahway, NJ)
- …10 years of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment OR a ... at least 6 of those in a regulatory and/or compliance area and experience with technical systems ... Systems , Change Management, Content Management, Content Management Systems (CMS), Cross-Cultural Awareness, Data Management, Data Quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Associate Director , Engineering as part of the Technical Operations team based in ... Raritan, NJ. Role OverviewThe Associate Director of Engineering is a strategic and operational leader responsible for the management, development, and performance of… more
