- 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
- 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
- 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
- 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
- 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
- Sanofi Group (Framingham, MA)
- …diseases and bring hope to patients and their families. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve ... compliant, and efficient operation and maintenance of Clean Utility systems. + Lead the sites cross-functional sustainability program to deliver Sanofi's Planet Care… more
- Bristol Myers Squibb (Devens, MA)
- …and provide Operations project information and activities status to Planning, Manufacturing, Quality Assurance / Operations, Global Supply and other associated ... and operational issues to prevent deviations and maintain a compliant environment. Lead and manage the development of corrective and preventative actions, deviation… more
- Olympus Corporation of the Americas (Westborough, MA)
- …. **Job Description** The Principal R&D Systems Engineer will lead or support Systems Engineering aspects on new product development ... collection of user needs/feedback on product requirements and concepts + Lead the requirements development and management process, incorporating risk management… more
- Bristol Myers Squibb (Devens, MA)
- …and provide Operations project information and activities status to Planning, Manufacturing, Quality Assurance / Operations, Global Supply and other associated ... and operational issues to prevent deviations and maintain a compliant environment. Lead and manage the development of corrective and preventative actions, deviation… more
- Bristol Myers Squibb (Devens, MA)
- …/ steering committee meetings for program team(s), prepares meeting materials with/for lead as requested, facilitates team meetings as needed, and documents actions ... senior leaders to drive decisions. + Monitor execution and quality to customer / stakeholder / sponsor standards. +...accomplishments and a proven track record. + Understanding of GMP and FDA regulatory requirements correlating to biologics. +… more