- Sanofi Group (Framingham, MA)
- …science, or equivalent + Experience preparing for and direct support of US FDA GMP Pre-Approval Inspections, and follow up activities (eg, inspection response ... **Job Title:** Global Quality Lead, GMP , GDP Audit and...+ Covers an international scope including major regulators; US FDA (USA), EMA (Europe), ANSM (France), National Medical Products… more
- System One (Devens, MA)
- …approve executed batch records; support lot disposition + Participate in internal audits, FDA inspections, and client audits + Support quality systems, document ... Title: Senior Quality Assurance Associate Location: Devens, MA Type: 6-month...5-7 years, or MS with 3-5 years in an FDA -regulated industry + Minimum 7+ years in GMP… more
- Merck (Boston, MA)
- **Job Description** We are seeking a dynamic and experienced Quality & Compliance Director to lead GMP compliance across our global network of internal and ... preventative actions (CAPA) are effectively implemented to maintain the highest quality standards **Key Responsibilities:** + ** GMP Compliance Leadership:**… more
- Actalent (Lexington, MA)
- …and regulatory compliance. + Maintain and enhance quality systems in alignment with GMP , GxP, and FDA regulations. + Lead CAPA initiatives and ensure timely ... + Quality Assurance + Audit Management + FDA Compliance + CAPA Oversight + GMP /GxP...GMP /GxP Knowledge + CDMO Experience Top Skills: + Quality Assurance + Audit + FDA +… more
- Integra LifeSciences (Braintree, MA)
- …MA in 2025. + Adequate knowledge of learning management software. + Experience in GMP and quality systems regulations ( FDA QSRs, ISO 13485:2016, CFR ... what's possible and making headway to help improve outcomes. The Senior Quality Compliance Specialist -Training will create and conduct training programs to enhance… more
- Rhythm Pharmaceuticals (Boston, MA)
- …management systems, and learning management systems. + Strong working knowledge of relevant FDA , EU, ICH GMP regulations and guidelines with proficiency in ... Amsterdam office to play a key role in ensuring quality and regulation-based compliance during the manufacture and distribution...be a key team member of the Technical Operations, GMP and GDP QA Group. Their main activities include… more
- Fresenius Medical Center (Waltham, MA)
- …knowledge in the interpretation of FDA guidelines, Good Manufacturing Practices ( GMP ) and relevant quality standards for pharmaceuticals and medical devices ... six core values supporting our promise to improve the quality of life of every patient every day. These...related industries + Several years of practical experience in FDA inspections and cooperation with US regulatory authorities (experience… more
- Integra LifeSciences (Braintree, MA)
- …challenging what's possible and making headway to help improve outcomes. The Senior Quality Engineer I - Design & Reliability Assurance (DRA) is responsible for the ... a seasoned professional engineer with complete and in-depth conceptual knowledge of quality engineering. They are knowledge of quality engineering best practices… more
- Nitto Denko Corp. (Milford, MA)
- …in Chemistry, Biology, Pharmaceutical Sciences, or related discipline. + 5+ years in GMP Quality Assurance within the pharmaceutical or biotech industry. + ... About this opportunity : The Senior Quality Systems Specialist, QA will be responsible for...of Change Controls, Deviations, CAPAs, Batch Records, and associated GMP documentation to ensure compliance with applicable regulatory standards… more
- Integra LifeSciences (Braintree, MA)
- …are challenging what's possible and making headway to help improve outcomes. The Quality Design and Reliability Assurance (DRA) Engineer II is responsible for the ... time (where applicable). + Support implementation of SPC programs with Manufacturing and Quality Control as a part of Process Validation and Design Transfer. +… more