- 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
- Eurofins (Cambridge, MA)
- …Perform complex GMP assays (PCR, ELISA, NGS, cell-based assays) + Lead method transfer, qualification, and validation for bioassays + Author/review SOPs and ... are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in… more
- Bristol Myers Squibb (Devens, MA)
- …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
- ThermoFisher Scientific (Franklin, MA)
- …support business needs.** **A Day in the Life** **We are seeking a dedicated professional to lead GMP Quality Control (QC) and Quality Assurance (QA) ... to ensure procedures and specifications are well-developed and effectively implemented.** ** Lead process quality initiatives by monitoring trends, identifying… more
- Sanofi Group (Waltham, MA)
- …view. **Scope** + Sanofi R&D Sites/ platforms, interactions with CMC, R&D Vaccines, Global Quality , Alliance Management, Global Regulatory Affairs, Clinical ... families. The purpose of this position is to provide quality technical management oversight of Sanofi sponsored GMP... manufacturing and testing of genomic medicines. Specifically, to lead the following activities: + Manage the quality… 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)
- …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
- Curia (Hopkinton, MA)
- …and drives Quality decisions at the site and also supports regional Director of Quality for global Quality initiatives + Provides hands on leadership and ... and packaging operations + Responsible for all aspects of GMP compliance. This includes quality oversight from...continuous improvement efforts + Ensure applicable requirements of Curia global Quality Systems are implemented and maintained… 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
- Catalent Pharma Solutions (Chelsea, MA)
- ** Quality Control Analyst IV** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission ... 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 Analyst IV who is a key analytical… more
- Meta (Boston, MA)
- **Summary:** Meta seeks highly engaged and experienced team players for lead roles to join our Design, Engineering & Construction (DEC) organization to direct ... join a high-powered team of industry leaders! **Required Skills:** Lead Contracts Manager - Data Center Design, Engineering &...team, peers, and outside business units to enhance the quality and efficiency of contracting processes. 12. Ensure all… more
- Nitto Denko Corp. (Milford, MA)
- …+ BS/BA in science or equivalent work experience with 3-5 years' experience in either GMP Production or Quality Assurance. + Ability to provide expert advice and ... you will be responsible for interfacing with and providing quality input to client's manufacturing programs that are in...commercial readiness, and that are approved to manufacture in global regions. Key Responsibilities: + Act as QA project… more
- Cambrex High Point (Waltham, MA)
- …Chemistry's state of the art complex-synthetics route development. Additionally, they will lead and advance the Quality Control function, collaborating with ... with the oversight of both analytical development activities and execution of Quality Control responsibilities. They will lead the analytical team, interface… more
- Olympus Corporation of the Americas (Westborough, MA)
- …usage. + Prepares, negotiates in the best interest of Olympus and executes global /regional and local quality assurance agreements on behalf of Olympus and ... is to coordinate the medium to long term Olympus quality strategy for externally sourced specific categories to provide...in all sites. + Executes remote Supplier audits as lead auditor. + Prepares, discusses, and reviews supplier surveys.… more
- Catalent Pharma Solutions (Chelsea, MA)
- ** Quality Control Analyst II** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission ... 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 Analyst who is responsible for executing QC… more
- Charles River Laboratories (Wilmington, MA)
- …business team meetings. ⦁ Provide assistance with the development and implementation of global GMP training programs to provide compliance managers and staff in ... can feel passionate about. **Job Summary** The Senior Director Global Head of Biologics Testing Quality will...Experience with Strategic M&A integrations ⦁ In-depth knowledge of GMP , governmental regulations, and other relevant quality … more
- Actalent (Framingham, MA)
- Job Description Lead and manage complex investigations related to deviations, non-conformances, and quality events across manufacturing, packaging, and ... root cause analyses and collaborate cross-functionally with Technical Operations, Manufacturing, Quality Control, and Regulatory Affairs to gather data and ensure… more
- Teleflex (Chelmsford, MA)
- …: Up to 10% **Requisition ID** :12097 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to improve ... the health and quality of people's lives. Through our vision to become...of healthcare. For more information, please visit **teleflex.com** . ** Global Operations -** Global Operations is a… more