- Sanofi (Framingham, MA)
- Job Title: Global Quality Lead , GMP , GDP Audit and Inspection - Pipeline Launch Location: Framingham, MA or Morristown, NJ About the Job We deliver 4.3 ... in Sanofi. Scope: Manufacturing & Supply, Research & Development, Countries, Digital, Global Quality organizations in Sanofi. And third parties outside of… more
- Vertex Pharmaceuticals (Boston, MA)
- …performing gap analysis, determining robust corrective actions, and risk communication. Serve as Quality Lead or provide support for projects of varied size and ... Attention to detail Knowledge in the following areas: Expert knowledge of global GMP requirements governing oral drug products and knowledge of… more
- Katalyst HealthCares and Life Sciences (Cambridge, MA)
- Responsibilities: Lead the strategic efforts in the interpretation of relevant and new quality guidelines to ensure that the current and phase appropriate ... review and finalizing the response. Review CMC supporting documents ( GMP certificates, Manufacturing/Import Authorization, CoA, QP declarations, MBR) and request… more
- Sanofi Group (Framingham, MA)
- **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
- Fresenius Medical Center (Waltham, MA)
- … and Compliance, Collaboration, No-Limits Mindset and Results Oriented. **PURPOSE AND SCOPE:** Lead Quality Systems Auditor will act as a Subject Matter Expert ... plans, conducts, and leads audits in accordance with the global QS audit program + Lead and...in the interpretation of FDA guidelines, Good Manufacturing Practices ( GMP ) and relevant quality standards for pharmaceuticals… more
- Bristol Myers Squibb (Devens, MA)
- …better place than here at BMS with our Cell Therapy team. The **Team Lead , Material Kitting & Delivery** role is responsible for providing on the floor supervision ... Provide coaching to Material Operations personnel in the areas of Safety, Quality & productivity + Collaborate with cross-functional employees & department managers… more
- Bristol Myers Squibb (Devens, MA)
- …3 years in risk management leadership position. + Expertise in GMP compliance, Quality System and global GMP regulations + Must have strong knowledge ... personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Director, Quality Risk Management will drive consistent Global Leadership… more
- Bristol Myers Squibb (Devens, MA)
- …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
- ThermoFisher Scientific (Plainville, MA)
- …Onsite** **Discover Impactful Work:** We are seeking a dynamic and strategic **Sr. Manager, Quality Control,** to lead all Quality Control operations at our ... a culture of quality and continuous improvement. + **Develop talent** : Lead and mentor an impactful QC team, driving engagement, capability, and career growth.… more
- Bristol Myers Squibb (Devens, MA)
- …a driven and experienced **Associate Director, Manufacturing and Process Support Innovation Lead ** to lead the transformation of Devens Cell Therapy business ... and implement transformational changes to improve overall patient throughput, product quality , and operational efficiency. + Identify, adopt, and integrate advanced… more
