- Eisai, Inc (Exton, PA)
- …Eisai is choosing, deploying and supporting computing platforms and solutions in compliance with applicable global regulations and in accordance with Eisai ... and deliverables.Minimum of 3 years work experience with pharmaceutical regulatory compliance and global regulations for computerized systems validationKnowledge… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for ensuring Daiichi ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Nordisk's life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well ... Lebanon, NH bioproduction facility. Relationships Reports to: Facilities and Maintenance Manager . Essential Functions Serves system administrator for the CMMS system… more
- 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
- Catalent Pharma Solutions (Harmans, MD)
- …meetings, and communication of CAPA -related metrics to key stakeholders. The CAPA Manager will collaborate with cross-functional teams to ensure quality ... **Senior Manager , CAPA ** **Summary:** _Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to… more
- Globus Medical, Inc. (Audubon, PA)
- …resume their lives as quickly as possible. **Position Summary** **:** The Senior Manager , CAPA (Corrective and Preventive Actions) and Complaints is responsible ... of quality-related issues related to customer complaints and regulatory compliance . This role ensures that CAPA and...FDA 21 CFR 820, ISO 13485, EU MDR, and global quality system regulations + Expertise in CAPA… more
- Catalent Pharma Solutions (Harmans, MD)
- …timely manner. The ** CAPA Specialist III** will work closely with the CAPA Manager and cross-functional teams to drive effective corrective and preventive ... CAPA ** **Summary:** _Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission...and processed in a timely manner. + Support the CAPA Manager in coordinating and facilitating … 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
- Stryker (Weston, FL)
- Stryker is hiring a **Senior Manager , NC/ CAPA ** to support **Joint Replacement (JR)!** In this role, you will lead the JR Division NC/ CAPA team, driving ... reasonable proximity to a Stryker facility. **What you'll do:** + Manage the NC/ CAPA team to ensure records are addressed effectively and timely. + Collaborate with… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- … Global Quality Systems. Provide guidance and perform a risk assessment for global CAPA and Deviation. Provides guidance to quality record owners to ensure ... Investigations, and Change Management for OPDC/OAPI. S/he is the Global process owner for the CAPA and...and maintenance of GMP/QMSR standards and processes to ensure compliance with local and global regulations. +… more
- Danaher Corporation (Brea, CA)
- …improvement activities. In addition, the CAPA GPO will also take on the role of CAPA Manager of the Global CAPA Review Board (CRB). This position ... governance and integration of the Corrective and Preventive Action ( CAPA ) process into our global Quality Management...is part of the Global Quality System and Compliance Group located… more
- Abbott (Pleasanton, CA)
- …to restore their health and get on with their lives. As a Senior Quality Compliance Manager , the individual will play a crucial role within Abbott's Heart ... compliance for Abbott Heart Failure organization. + Oversee division's compliance lifecycle, CAPA System and External Requirements Management System. +… more
- Howmet Aerospace (Cleveland, OH)
- Job Summary: + Lead and manage the global supplier quality function, ensuring consistent compliance with ISO 9001 and IATF 16949 standards across all supplier ... risk mitigation, and process reliability. + Collaborate cross-functionally with global procurement, engineering, and manufacturing teams to resolve supplier issues,… more
- Regeneron Pharmaceuticals (Troy, NY)
- The Director, Global Procurement Compliance will be responsible for directing a team of Compliance Managers and Specialists that support and maintain all ... cGMP compliance aspects of procurement operations. In addition to leading...team this individual will be a member of the Global Procurement Direct Category Leadership team and will provide… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). **Let's realize your potential, together.** It ... This role plays a critical role in strengthening the organization's compliance posture by integrating external regulatory insights with internal quality and… more
- Bristol Myers Squibb (Princeton, NJ)
- …and observation resolution through CAPA . + Drive lab and site compliance to regulatory, enterprise, and global requirements through building positive ... with a minimum of 5 years of clinical lab operations, quality and/or compliance ; experience in pharma, biotech, CRO, or medical device preferred. MS in relevant… 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
- Abbott (Columbus, OH)
- …projects by following root cause, corrective and preventative best practices. Ensure CAPA compliance to Abbott policies and procedures. + Lead investigations ... serve people in more than 160 countries. **Quality Program Manager - Supplier Quality Packaging ( Global SQA)**...of innovation and ongoing capacity and growth. Maintain a compliance and food safety-focused mindset, ensuring the team is… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- **Investigation Manager , Technical Services** **Position Summary** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) ... and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments… more
- Abbott (Lake Forest, IL)
- …**Lake Forest, IL** has currently an open position for **Quality Systems, Regulatory Compliance Manager ** . This person will be responsible for quality systems ... Abbott is a global healthcare leader that helps people live more...examples include but not limited to: QMS Monitoring, Nonconformance/ CAPA , and PRRC (Person Responsible for Regulator Compliance… more
