- 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)
- …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
- 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
- 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
- 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
- Symmons Industries (Braintree, MA)
- …all products meet or exceed company and industry standards, implement effective quality control systems, and lead initiatives to drive continuous improvement. ... quality metrics, ensuring continuous improvement in product quality and process performance. + Lead efforts...+ Knowledge of regulatory requirements and industry standards (ISO, GMP , etc.). + Ability to manage multiple priorities in… 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 (QC) Analyst II who is responsible for… more
- Zimmer Biomet (Braintree, MA)
- …in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient's mobility is enhanced ... respected, empowered and recognised. **What You Can Expect** Maintain Site Quality programs to ensure compliance to domestic and international medical device… more
- ThermoFisher Scientific (Plainville, MA)
- … testing. + Build a trained, competent team of QC analysts to support GMP testing. + Coordinate daily Quality Control activities for Molecular, Viral, Cell, ... (Mon-Fri) **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Laboratory Setting, Office **Job Description** As part… 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