- 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
- 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
- Insight Global (Boston, MA)
- …Key Responsibilities: -Triage manufacturing issues in real-time on the manufacturing floor. - Lead and write investigations for quality events using root cause ... Job Description We are seeking a Senior Quality Records Specialist to join our Manufacturing Technical Operations (MTO) team in Boston. This role involves complete… 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
- 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
- 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
- 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
- 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
- Takeda Pharmaceuticals (Lexington, MA)
- …to the best of my knowledge. **Job Description** **About the role:** As a Quality Control Senior Analyst, you will focus on the daily lab operations and execution ... derived from the compendia and non-compendial sources. You will maintain operational and GMP readiness of the QC area. Also, you will participate in more complex… 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
- Takeda Pharmaceuticals (Lexington, MA)
- …compliance with quality requirements. You will report to the Complaints Lead . **How you will contribute:** + Define and specify activities, processes, and ... with a minimum of 5‐9 years of experience in Quality Assurance or a GMP related field...you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation,… more
- Bristol Myers Squibb (Devens, MA)
- …flow cytometry). Lead site implementation of automation systems into the GMP QC laboratory. + Work with internal automation development team and external ... laboratory investigations. + Champion and foster a positive and successful collaborative quality culture. + Conceptualize and lead complex projects, CAPAs,… more
- Hologic (Marlborough, MA)
- …ISO 14971), MDSAP, and other global regulatory requirements. + Expertise in Quality Systems and GMP compliance in regulated industries such as medical ... a pivotal role in ensuring the effectiveness of our global Quality Systems. In this critical leadership...training. + Minimum of 10 years of experience in Quality Systems and GMP within medical devices,… more
- Sanofi Group (Framingham, MA)
- …and change management. OpEx teams collaborate with all functions at the site, with Global SMS and actively contribute to the Sanofi SMS network. This role serves as ... 2) improve site competitiveness by leveraging supplier performance, 3) support and/or lead risk management (single source risks and driving initiatives related to… more
- Teleflex (Chelmsford, MA)
- …: Up to 10% **Requisition ID** :12166 **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
- Charles River Laboratories (Wilmington, MA)
- …with accuracy and meet client's expectations/timelines * Proactively Assist or lead proposal process improvement projects/initiatives * Coordinate all aspects of the ... sales proposal document production process to ensure the overall quality meets company and client standards * Research appropriate responses through supplied… more