- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
