- 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)
- …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
- Merck & Co. (Rahway, NJ)
- …Machine Learning (ML), Manufacturing Processes, Mechanical Testing, Medical Device Quality Systems , Medical Device Regulations, Medical Devices, Medical ... medical device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.--… more
- Merck & Co. (Rahway, NJ)
- …Manager to join the RaDS Product organization. The position will report to the Lead of the Disease Biology and PharmTox Product Line. The ideal candidate will ... frameworks; manage backlog and release planning- Manage scientific applications and lead squads to build user-friendly scientific data and technology products;… 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)
- …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)
- … Quality Control, Microbiology, Molecular Microbiology, Physiology, Process Improvements, Quality Assurance (QA), Quality Assurance Systems {+ ... Job DescriptionThe Rahway based Senior Specialist, Global Development Quality Operations, is responsible for independent approval of documentation to support GMP… 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)
- Job DescriptionDirector, Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and ... Systems COE, the Director, Global Distribution Engineering and Technology,...for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Logistics… 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
- 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
- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.- Working independently, the ... limited to: - Interacts closely with key partner organizations (as a lead GCS Planning program representative) such as clinical development, regulatory, quality… 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
- Merck & Co. (Rahway, NJ)
- …Manufacturing Processes, Mechanical Engineering, Mechanical Testing, Medical Device Quality Systems , Microscopies, Negotiation, Optical Microscopy, Product ... systems .Self-motivated with ability to work independently.Proven ability to lead teams of diverse skill sets and backgrounds.Strong interpersonal skills and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and procedures for the signaling activities to ... continuous improvement around development of new signal workflow/process, development of quality systems and tools, updates to templates and procedural… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and problem solving program to improve safety, compliance, cost, process stability building quality and efficiency into processes to improve lead times and ... cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will lead continuous improvement initiatives with various site functions to support of… more
- ValSource, Inc. (Rahway, NJ)
- …projects directly at client sites, ensuring that pharmaceutical manufacturing processes and systems meet regulatory and quality standards. This role involves ... currently looking to identify experienced and technically skilled leaders with Project Lead and Project Management experience to support a variety of exciting… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …working within an aseptic manufacturing facility, preferably in training/system applications, quality systems , or learning management systems .Knowledge of ... execution.Knowledge of LMS system.Supports the maintenance and reporting of quality training metrics.Support daily manufacturing activities when necessary. RequirementsA… more
