- Sanofi Group (Morristown, NJ)
- **Job Title:** Global Quality Lead , GMP , GDP Audit and Inspection - Pipeline Launch **Location:** Framingham, MA or Morristown, NJ **About the Job** We ... in Sanofi. + **Scope:** Manufacturing & Supply, Research & Development, Countries, Digital, Global Quality organizations in Sanofi. And third parties outside of… more
- Bristol Myers Squibb (Madison, NJ)
- …External Manufacturing, Regulatory Affairs and Brand teams. The individual provides end-to-end global quality oversight of all cell therapy development programs ... for cell therapy commercial, clinical and development products. + Acts as lead Quality management reviewer/approver of regulatory submissions and responses to… more
- Berry Global (Monroe, NJ)
- …by First Article and In-Process Inspection procedures and assigned by the Lead Inspector. Follow all work instruction related to in process inspection. 3.2 ... Conduct daily dimension as required by department procedures, or Lead Inspector. 3.3 Clearly document Inspection results on Inspection sheets maintaining GMP … more
- Merck (Rahway, NJ)
- **Job Description** The **Senior Specialist, Rahway Drug Product Disposition, Global Development Quality ** is responsible for independent approval of ... clinical supply disposition commitments and maintenance of a cGMP posture within Global Development Quality . + Support preparations for regulatory agency… more
- Merck (Rahway, NJ)
- …assigned projects including clinical supply disposition commitments and maintenance of a current GMP posture within Global Development Quality . + Adhere to ... other applicable worldwide regulations and our Company procedures. Collaborates with the Quality Program Lead to issue reports summarizing results, works with… more
- Bristol Myers Squibb (Summit, NJ)
- …better place than here at BMS with our Cell Therapy team. The ** Lead Project Engineer, Equipment Commissioning and Qualification (ECQ)** Delivery, plays a key role ... to meet business needs in accordance with required schedules or dates. + Lead and oversee contract project teams to ensure timely execution and adherence to… more
- Bristol Myers Squibb (Summit, NJ)
- …as the Global Technical SME for Drug Product and Vector Validation. The lead will develop global technical standards for cell therapy validation and deploy ... providing SME assessment for proposed process life-cycle changes. The lead will serve as the Global Point...global cell therapy validation technical standards via the quality system. + Promote innovative and efficient approaches to… more
- Merck (Rahway, NJ)
- **Job Description** This position reports to the Associate Director, Global Clinical Supplies Quality and is critical to maintaining the global clinical ... experience in the pharmaceutical or equivalent industry Good Manufacturing Practice ( GMP ) related field including Technical, Engineering, Quality or Operations.… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …The Vice President of Central Quality Operations will lead and influence Quality strategy for Gilead Global Quality Management System (QMS) and the ... significant impact across many areas as the QMS and Global Market GMP /GDP activities are core to...of findings to key stakeholders, essentially acting as the lead quality expert in ensuring the report… more
- Merck (Rahway, NJ)
- …strong working knowledge of microbiology laboratory practices and procedures in a GMP environment including microbiology data review and quality procedures. This ... passion for improving human health. As part of our global team, you will have the opportunity to collaborate...biologic, and vaccines finished drug products. + Troubleshoot and lead any investigations associated with GMP testing… more
- Sanofi Group (Morristown, NJ)
- …and high- quality responses and support the development and promotion of Global Quality Documentation. + Supports the preparation, execution and closure of ... purposes, and ensuring accurate reporting to Operations Management and Global Quality . . **Core member of critical.... . **Core member of critical governance** + Sanofi's GMP GDP Quality Council to facilitate sharing… more
- Actalent (Piscataway, NJ)
- …Apply working knowledge of applicable regulations and standards (eg, ISO, FDA, CAP, CLIA, GMP , GCP, GLP, ICH, and other global standards) to provide regulatory ... Job Title: Quality Assurance and Regulatory Affairs SpecialistJob Description As...applicable regulations and standards (eg, ISO, FDA, CAP, CLIA, GMP , GCP, GLP, ICH, and other global … more
- Bristol Myers Squibb (New Brunswick, NJ)
- …medicines of tomorrow based on the cutting - edge science of today. Working within Global Product Development and Supply this team uses state - of - the art ... e xecute analytical and CMC strategies that ensure safety, quality and efficacy of life - saving medicines administered...candidate will be part of the Analytical Regulated Testing GMP team at BMS New Jersey within Analytical Strategy… more
- Merck (Rahway, NJ)
- …stakeholders, subject matter experts, and customers both within and outside of Global Clinical Supply (GCS). Your leadership will be instrumental in driving ... readiness for the expanding landscape of on-site clinical capabilities. + Lead efforts to sustain inspection readiness by implementing standardized workstreams. +… more
- Merck (Rahway, NJ)
- …data analytics/visualization software. + Familiarity with Good Manufacturing Practices ( GMP ) requirements, quality procedures, and Standard Operating Procedure ... **Job Description** The Global Clinical Supply (GCS) organization is accountable for...internal and external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.… more
- Lilly (Branchburg, NJ)
- …The Analytical Technical Steward works closely with development counterparts and GQL ( Global Quality Laboratories) to ensure robust analytical control strategies ... facilitate updating packages as needed. + Participates in method validations according to Global Quality Standards (either to bring methods up to current… more
- Mondelez International (East Hanover, NJ)
- …of goods sold eg route to market, capacity utilization, DIOH, manufacturing efficiency, quality , safety. Lead AR development. + Manage and deliver assigned ... You Ready to Make It Happen at Mondelēz International?** **Join our Mission to Lead the Future of Snacking. Make It Uniquely Yours.** This role is responsible for… more
- Merck (Rahway, NJ)
- …creativity, effective interpersonal and collaborative skills + Demonstrated ability to lead teams to deliver high- quality results against firm deadlines ... technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate...the Raw Materials and Medical Devices/Combination Products (MDCP) will lead a team of specialists and scientists in Rahway… more
- Wolters Kluwer (New York, NY)
- …month in the office (see approved locations on the posting). **OVERVIEW** You will be the global product quality lead in support of a broad portfolio of ... + Manage and guide system testing activities, including verification and validation. + Lead resolution of quality issues with on-market device software; drive… more
- Astrix Technology (New Brunswick, NJ)
- …-compliant pharmaceutical or biotechnology environment. **Key Responsibilities:** + Lead and coordinate microbiological testing activities, including product release ... logs to ensure compliance with cGMP, FDA, and company quality standards. + Participate in or lead ...preferred). + 10+ years of experience in microbiology or quality control within a GMP -regulated pharmaceutical or… more