- Hologic (Marlborough, MA)
- Global CAPA & Compliance Manager Marlborough, MA, United States Are you an experienced Quality leader with a passion for compliance and driving ... impactful change? Hologic is seeking a Global CAPA and Compliance Manager to oversee and ensure a robust and compliant CAPA and Nonconforming… more
- Fresenius Medical Center (Waltham, MA)
- …project direction throughout CAPA stages. Performs Quality Approver functions for CAPA and NCs to ensure compliance to applicable procedures. + Applies ... cause, corrective action(s) and monitoring plan(s) for resolution of CAPA and NC issues. + Applies technical/ compliance ...necessary requirements from FME Quality Management and formerly used NC/ CAPA tools into one global electronic NC/… more
- Curia (Burlington, MA)
- …MA Build your future at Curia, where our work has the power to save lives. The Manager , Global Quality Systems and Compliance is an integral part of the ... Manager , Quality Systems and Compliance -...applicable regulations and business goals and objectives * Ensure compliance with global regulatory requirements (eg FAD,… more
- Bristol Myers Squibb (Devens, MA)
- …to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. The Manager , Shop Floor Quality Assurance, Cell Therapy is ... in accordance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Functional responsibilities include ensuring operational compliance … more
- Astellas Pharma (Westborough, MA)
- ** Manager , Quality Assurance** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to ... of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of… more
- Sanofi Group (Framingham, MA)
- …for our patients and assuring the security of the company's business and global markets. The Principal Compliance Specialist is responsible for providing quality ... **Job Title:** Principal Compliance Specialist, Operations **Location:** Framingham, MA **About the...to the QA team in the absence of the manager . We are an innovative global healthcare… more
- Actalent (Waltham, MA)
- Responsibilities + Support the internal audit program and manage CAPA processes. + Assist in the Vendor Management program and run the validation master plan. + ... development of new quality systems. Essential Skills + Expertise in quality assurance, compliance , and internal audits. + Proficiency in audit readiness, CAPA ,… more
- Bristol Myers Squibb (Devens, MA)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . ** Manager , Quality Engineering Cell Therapy,** **Bristol-Myers Squibb Company** **,** ... risk assessment and Electronic Records & Electronic Signatures (ERES) Assessment in compliance with Food and Drug Act (FDA) regulations and company policies. Review… more
- Kelly Services (Norwood, MA)
- …13485** **requirements** + **Hands-on experience with:** + **Root cause analysis and CAPA processes** + **Regulatory compliance (eg, medical device reporting, ... **Quality Control Manager ** _Location: Norwood, MA (Relocating to Walpole, MA..._Salary: $70,000 - $100,000+ (Commensurate with Experience)_ Join a global leader in electro-mechanical and cable assembly manufacturing! Established… more
- Bristol Myers Squibb (Devens, MA)
- …no better place than here at BMS with our Cell Therapy team. The ** Manager , Cell Therapy Supply Chain** is responsible for management and oversight of critical ... indirect impact on Manufacturing This is a direct people manager role where the manager will be...corresponding documentation in SAP and other electronic systems **Quality, Compliance , Safety, and Integrity:** + Triage quality events with… more
- Actalent (Ayer, MA)
- Job Title: QA Manager The QA Manager is also tasked with reviewing and auditing sanitation and operational practices, implementing specifications on raw ... materials, conducting Quality GMP trainings, and maintaining compliance with SQF GFSI food safety standards. Responsibilities + Directly manage a team of up to 10… more
- Bristol Myers Squibb (Devens, MA)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position: Manager , Validation Engineer, Cell Therapy** **Location: Devens, MA** **Key ... Controls. + Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures. + Applies strong technical skillset… more
- Bristol Myers Squibb (Devens, MA)
- …in their personal lives. Read more: careers.bms.com/working-with-us . BMS is a global biopharmaceutical company leading the way in medical innovation to help ... 1 to join the raw materials team within the Cell Therapy GMSAT ( Global Manufacturing Science and Technology) department. The Raw Materials team is responsible for… more
- Actalent (North Billerica, MA)
- …manage and contribute to CMC-related projects and initiatives, ensuring compliance with regulatory, scientific, and technical criteria. Responsibilities + Qualify ... development, process control, and analytical methods. + Ensure quality assurance and compliance with GMP knowledge, including change control, deviation, and CAPA… more
- Actalent (North Billerica, MA)
- …assess risks, and develop strategic plans. + Ensure quality assurance and compliance with GMP standards, including change control, deviation, and CAPA . ... is anticipated to close on Jun 3, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary… more
- Medtronic (Danvers, MA)
- …Engineer II** who is passionate about ensuring product quality and regulatory compliance in support of innovative medical devices. In this role, you'll contribute ... a regulated manufacturing environment + Lead and support nonconformance investigations, CAPA (Corrective and Preventive Actions), and root cause analysis + Perform… more
- Sanofi Group (Framingham, MA)
- …and proposes CAPA for minor deviations. + Supports Manufacturing Operations Manager and Manufacturing Specialist in the investigation, closure, and CAPA ... **Job Title:** Business Title Manufacturing Supervisor **Hiring Manager :** Caroline Gabriele de Paula **Location** : Framingham,...to patients and their families. We are an innovative global healthcare company with one purpose: to chase the… more
- Sanofi Group (Framingham, MA)
- …alignment with the organizational strategy, vision, and objectives We are an innovative global healthcare company with one purpose: to chase the miracles of science ... and Qualification/Validation for processes (microbio strategy) + Ensuring the ** compliance of products and processes** with applicable contamination control… more
- Actalent (Waltham, MA)
- …and production equipment. + Develop test plans, inspect, and assess material compliance based on dimensional and attribute acceptance criteria, while documenting and ... for processing. + Manage Root Cause Analysis activities stemming from MRB, RMA, and CAPA . + Analyze and trend non-conformances through NCMRs and RMAs. + Assist in… more