- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Rhythm Pharmaceuticals (Boston, MA)
- Company Overview Rhythm is a global , commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare ... team in Boston, Massachusetts. The Associate Director will be the technical lead for Drug Product small molecule drug product development, manage outsourced… more
- Sanofi Group (Framingham, MA)
- …people from infectious diseases and bring hope to patients and their families. To lead and develop EM North American DP team to ensure achievement of business goals ... and targets with high level of customer service & quality and in full compliance with Sanofi standards and...markets serviced from North America. We are an innovative global healthcare company with one purpose: to chase the… 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
- ThermoFisher Scientific (Boston, MA)
- …(Days) **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards **Job Description** At Thermo Fisher Scientific, you'll ... meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission...and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people… more
- Sanofi Group (Framingham, MA)
- …campus: (1) MABC Biologics - comprised of commercial Fabrazyme, Thyrogen and Global Cell Banking operations. (2) MABC Campus Facilities Operations - responsible for ... business continuity. This organization is also responsible for shared GMP systems on the Framingham campus as defined by...of small scope and complexity. We are an innovative global healthcare company with one purpose: to chase the… more
- ThermoFisher Scientific (Boston, MA)
- …developing and executing a strategic sales plan to maximize business from your assigned global key accounts. In this pivotal role, you will drive revenue growth by ... assigned Key Accounts. Develop specific strategies for success with target global accounts. Assess client satisfaction and recommend opportunities to improve. Ensure… 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
- Sanofi Group (Framingham, MA)
- …with the manufacturing instruction set and current GMPs. We are an innovative global healthcare company with one purpose: to chase the miracles of science to ... generation. + Interacts with other support functions such as Quality Assurance, Quality Control, Manufacturing Engineering, MSAT,...less experienced operators. + Fulfills the role of Team Lead in the absence of the Sr. Manufacturing Associate.… more