- 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
- 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)
- … 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)
- …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
- 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
- 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
- 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
- Merck & Co. (Rahway, NJ)
- …at the Rahway (RY) NJ Campus. - This role ensures HVAC systems comply with regulatory standards (eg, FDA, cGMP), maintain optimal environmental conditions ... for product quality , and support continuous operations. The ideal candidate will...for the daily operations, troubleshooting, and optimization of HVAC systems for both commercial office buildings and pharmaceutical laboratories… 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
- Merck & Co. (Rahway, NJ)
- …control environment at our company.On occasion, the incumbent will be expected to lead small teams of auditors audits with limited management supervision in addition ... papers (including walkthroughs and sample testing) in line with the established quality standards and timelines.Collaborate with the audit team in the writing of… more
- Merck & Co. (Rahway, NJ)
- …and execution, along with leadership skills to shape the technical capabilities lead a global, cross-modality technical team.The Associate Director will lead ... testing and qualification and leading execution of qualification of complex systems .-The candidate is expected to build inclusive, collaborative partnerships with… more
- Merck & Co. (Rahway, NJ)
- …payers, policymakers, health technology assessment (HTA)/ reimbursement agencies, and health systems globally. The ability to successfully participate in and lead ... and strategic direction to teams leading the development and execution of high- quality evidence strategies and plans.Ensures that the Value & Implementation (V&I)… more
- Merck & Co. (Rahway, NJ)
- …control environment at our company.On occasion, the incumbent will be expected to lead small teams of auditors audits with limited management supervision in addition ... papers (including walkthroughs and sample testing) in line with the established quality standards and timelines.Collaborate with the audit team in the writing of… 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
- 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
