- 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
- Takeda Pharmaceuticals (Lexington, MA)
- … quality liaison between Biologics Business Unit senior management and Global Quality , Regulatory Affairs, and Operations, fostering seamless communication ... product quality reviews. Maintains alignments across supporting Global Quality (GQ) and Biologics functions involved...quality issues effectively. + **Product Launch Oversight** : Lead quality oversight during product launch and… 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
- Actalent (Lexington, MA)
- …external audits, investigations, and regulatory compliance. + Maintain and continuously improve quality systems in accordance with GMP , GxP, and FDA ... Provide strategic direction, mentorship, and development opportunities for the Quality team. + Prepare for and lead ...in a Life Science discipline. + Deep understanding of GMP , GxP, and FDA regulations. + Demonstrated success managing… more
- Bristol Myers Squibb (Devens, MA)
- …BioPharma Operating Units, the Sr. Director, BI&T, Devens Digital Plant and Site BI&T Lead will be directly accountable to the US Biologics Leader and Devens Campus ... a standing member of the Devens Campus leadership team. **Key Responsibilities:** + Lead a matrixed organization composed of both site direct reports and groups of… more
- Sanofi Group (Framingham, MA)
- …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
- Bristol Myers Squibb (Devens, MA)
- …solutions. + Performs tasks in a manner consistent with the safety policies, quality systems, and GMP requirements. Completing training assignments to ensure the ... Cell Therapy team. BMS Cell Therapy Manufacturing seeks a **Specialist, Lead Manufacturing Associate Cell Therapy** that brings enthusiasm, intellectual curiosity,… more
- Catalent Pharma Solutions (Chelsea, MA)
- ** Quality Control Analyst IV - Tech Transfer Team** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization ... and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing...in North America. Catalent Pharma Solutions is hiring a Quality Control (QC) Analyst IV who is a key… more
- Takeda Pharmaceuticals (Lexington, MA)
- …etc. in conjunction with senior staff and global line and function heads + Lead global CMC and Quality key initiatives and represent Pharm Sci to ... my knowledge. **Job Description** **How you will contribute:** + Lead and develop a global team of...Stability and Shelf life; c) Reference Standard Management; d) GMP Quality Systems + Contribute to product… more