- Terumo Medical Corporation (Somerset, NJ)
- …and applicable regulatory requirements, while driving continuous improvement in clinical quality systems and processes. Key responsibilities include planning and ... Sr. Clinical Quality Specialist Date: Oct 21, 2025 Req ID:...is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. We believe that the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based ... in Raritan, NJ. Role OverviewThe Quality Systems Lead role is an exempt level position with responsibilities for supporting the quality systems … more
- Terumo Medical Corporation (Somerset, NJ)
- …to patient safety and product quality by maintaining compliance with all TMC Quality Systems requirements. This includes but is not limited to the prompt ... of contracts that involve the sale of Terumo product, to ensure high quality contracts that are effective, equitable and compliant. The Contract Analyst will work… more
- Terumo Medical Corporation (Somerset, NJ)
- …Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications for ... drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of...is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. We believe that the… more
- Terumo Medical Corporation (Somerset, NJ)
- …Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications for ... drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of...is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. We believe that the… more
- Terumo Medical Corporation (Somerset, NJ)
- …Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications for ... drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of...is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. We believe that the… more
- Terumo Medical Corporation (Somerset, NJ)
- …Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high- quality medical devices used in a broad range of applications for ... drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of...is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. **Job Summary** SAP RTR… more
- Terumo Medical Corporation (Somerset, NJ)
- …benefits of company products to Key Opinion Leaders (KOL), medical groups and health systems . + Meet with local and regional thought leaders as frequently as is ... unsolicited scientific inquiries of Health Care Providers (HCPs)/investigators/health care systems /academic medical centers and population health decision makers integrating… more
- Genscript USA Inc. (Piscataway, NJ)
- …matter expert (SME) for mechanical, electrical, and plumbing (MEP) systems —particularly HVAC—during major facility construction and expansion projects (230,000+ sq ... is essential. This role offers a rare opportunity to design foundational systems for how we manage equipment and facilities, while also driving in-house… more
- Genscript USA Inc. (Piscataway, NJ)
- …cross-functional teams is essential to ensure supply continuity, compliance with quality and regulatory standards, and readiness for audit requirements. The ... item replenishment to meet inventory KPIs while ensuring continuity of supply. Lead strategic sourcing and manage the procurement process for direct materials and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …OOS monitoring and trending program)Contribute to developing and/or improvements to quality systems in support of global implementation of changes ... initiatives.Experience in developing, writing and approving technical documents.Experience with Quality systems (Change control, investigations, LIMs, etc.).Extensive… more
- Merck & Co. (Rahway, NJ)
- …Business Systems , Change Management, Content Management, Content Management Systems (CMS), Cross-Cultural Awareness, Data Management, Data Quality ... ONSITE 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. The… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe're looking for a Director of Quality Assurance to lead quality across the full value chain for a late-stage ophthalmic program. In this ... teams; advise, problem-solve, and drive continuous improvementImplement and oversee fit-for-purpose Quality Management Systems and standard ways of workingStay… more
- Merck & Co. (Rahway, NJ)
- …Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of Excellence (COE) is responsible and accountable for ... molecule bulk and primary packaging components and packaging master data and systems .The Packaging Technical Operations organization aims to be an industry leader in… more
- Merck & Co. (Rahway, NJ)
- … Auditing and Supplier ManagementThe Director will report to the Animal Health Global Quality Lead for Compliance and Technical Support and will direct the below ... qualification through ongoing training and continuing education programs.Coordinate with Site Quality leads on audit refusals and postponements. Lead project… more
- Formation Bio (New York, NY)
- …them for regulatory inspections. Overseeing the development, implementation, and upkeep of quality systems and procedures, including SOPs, batch records, and ... and external teams to implement corrective and preventive actions. Lead the quality review process, ensuring the...requirements, including GMP, GCP, and ICH guidelines. Expertise in Quality Management Systems (QMS). Extensive knowledge of… more
- Avet Pharmaceuticals Inc (East Brunswick, NJ)
- …achieving process improvements and associated operating efficiencies * Familiarity with Quality systems and compliance expectations across geographies. Able to ... and logistics to support manufacturing operations while partnering with Manufacturing, Quality , Sales, Marketing, and Finance. Leads the monthly S&OP processes… more
- Merck & Co. (Rahway, NJ)
- …of contact for manufacturing leadership, engineering, commercial teams, supply chain, quality , IT, and external partners/vendors. Lead stakeholder engagement ... security requirements appropriate for industrial environments. Requirements definition & systems design Lead scoping, requirements definition, and prioritization… more
- Merck & Co. (Rahway, NJ)
- …acceptable related experience.Required Experience and Skills:- Strong knowledge of cGMP, Quality Systems , Safety, Environmental, data integrity, and validation ... databases/historians, and basic system administrationExperience with electronic validation and quality systems (eg, Kneat/eVal, Veeva)Prior leadership of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of successful Health Authority inspections and approvals - Proactively partner and lead the strategic collaboration with other GxP Quality representatives, and ... Management Process for the respective business areas.Responsibilities:Leadership and Project Management: Lead the end-to-end quality execution across Medical… more
