- Cytiva (Marlborough, MA)
- …for Cytiva is responsible for supporting the Business and Customers in a global environment by providing quality documents and regulatory support in ongoing ... delivery.What you'll do:Support the Business and Customers in a global environment by providing quality documents and...in Biochemistry/Chemistry or related field3+ years of experience in GMP , quality , product management or a related… 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
- Astellas Pharma (Westborough, MA)
- **Validation Lead , Quality Assurance** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are ... is headquartered in Massachusetts. Astellas is announcing a **Validation Lead , Quality Assurance** opportunity at their **Astellas...policies and procedures and industry best practices. The Validation Lead will ensure that all critical GMP … 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)
- …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)
- …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
- 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
- Medtronic (Billerica, MA)
- …and compensation plans (https://www3.benefitsolver.com/benefits/BenefitSolverView?page\_name=signon&co\_num=30601&co\_affid=medtronic) We lead global healthcare ... for this opening will close on - 11 Jun 2025 Position Description: Principal Quality Engineer for Medtronic, Inc located in Billerica, MA. Develop, modify, apply and… 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
- Danaher Corporation (Marlborough, MA)
- …for Cytiva is responsible for supporting the Business and Customers in a global environment by providing quality documents and regulatory support in ongoing ... do: + Support the Business and Customers in a global environment by providing quality documents and...or related field + 3+ years of experience in GMP , quality , product management or a related… more
- Actalent (North Billerica, MA)
- Job Title: Quality InvestigatorJob Description Lead and manage complex investigations related to deviations, non-conformances, and quality events across ... with internal procedures and regulatory expectations. + Facilitate and lead cross-functional team meetings focused on deviation management and investigation… 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
- ThermoFisher Scientific (Waltham, MA)
- …**Position summary** The Sr. Director, Compliance will be a valued member of the Global Quality Leadership team, reporting to the Vice President, Global ... implementation of compliance processes and systems in a manner consistent with global quality systems requirements, corporate standards, current regulatory and… 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
