- 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …of QA across GxP (GCP/GVL/GCLP/GLP) systems. + Lead the development of the global Data Integrity strategy and promote a quality culture throughout the ... Champion and disseminate educational materials and initiatives related to quality concepts across global teams. Lead ...including IT and Compliance Risk Management as well as Global QMS, QMS ( GMP -QA).Ensure leadership oversight 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
- Catalent Pharma Solutions (Somerset, NJ)
- **Job Title: Global Director, Continuous Improvement** **Location: Bridgewater, NJ** **Position Summary** The focus of this role will be identifying and implementing ... and late-stage clinical products efficiently, timely, and with high quality . Scope of the role covers the entire product...delivery of the cost transformation across the company. The Global Director Continuous Improvement will be part of the… 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
- 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global Quality teams located in EU, Americas (including Brazil) ... disorders. **JOB SUMMARY** The Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is...Medical Affairs LT, Specialty MA LT, Development (as applicable), GMP QA, and engagement with external partners as deemed… 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 (Summit, 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary** + This role is key leadership position within Global QMS and Global Quality Assurance. Overall accountability is ... for Global GxP activities **Responsibilities** **Training Function** + Team Lead development of strategies for the needs assessment, design, planning, delivery,… 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