- 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
- 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
- Sanofi Group (Framingham, 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
- 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
- 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
- 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 (Waltham, MA)
- …**About the Job** As an experienced mRNA CMC Principal Statistician, you will lead and coordinate the team providing statistical support to the mRNA CoE scientists ... mRNA vaccines and therapeutics development and launch. We are an innovative global healthcare company that helps the world stay ahead of infectious diseases… 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
- 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
- Wolters Kluwer (Waltham, MA)
- …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
- Medtronic (Billerica, MA)
- …(https://www3.benefitsolver.com/benefits/BenefitSolverView?page\_name=signon&co\_num=30601&co\_affid=medtronic) **About Medtronic** We lead global healthcare ... County Fair Chance Ordinance for Employers and the California Fair Chance Act. We lead global healthcare technology and boldly attack the most challenging health… more
- Sanofi Group (Framingham, MA)
- …hope to patients and their families. You will be part of Sanofi Global Engineering's Manufacturing Systems & Automation department, embedded within project teams for ... region. This pivotal role offers a unique opportunity to influence the global manufacturing strategy through innovative solutions. You'll work with a dynamic team… more