- Regeneron Pharmaceuticals (Rensselaer, NY)
- We are currently looking to fill a Director of GMP Compliance & Inspections position. This position will work with cross-functional teams to drive ... will ensure a state of continuous GMP compliance in Regeneron IOPS and to build inspection...we are performing with in compliance . The Director will also provide support during regulatory inspections… more
- University of Rochester (Rochester, NY)
- …GCPs, GLPs, and other regulatory agencies (eg OSHA), including the need to serve as on-site director in compliance with 21 CFR Part 210 & 211. + Responsible to ... of international regulatory standards as necessary to maintain internal and regulatory compliance . Participate in external and internal inspections from client… more
- Regeneron Pharmaceuticals (Troy, NY)
- …on the IOPS CMC intelligence program + Collaborates with the Regulatory Intelligence and GMP Compliance and Inspections teams to support and drive activities ... The Director of CMC Industry and Regulatory Intelligence is...for enabling chemistry manufacturing and controls (CMC) quality and compliance excellence by ensuring Regeneron IOPS maintains effective systems… more
- Pfizer (New York, NY)
- …infrastructure and system initiatives for all groups in RQA (GCP, PV, GLP, GMP , Inspection Management, Quality Management System and Operations) to ensure ... **ROLE SUMMARY** The Director , Quality Digital Team Lead is responsible for...a partner to the RQA leadership team/ audit & inspection leads, Digital, and other quality groups in Pfizer.… more
- Mallinckrodt Pharmaceuticals (Hobart, NY)
- …Hobart site. Develops and implements a comprehensive EHS Program that is in compliance with Mallinckrodt and regulatory requirements. Acts as a program and project ... EHS and the site. Tracks environmental, OSHA and biological safety compliance , monitors performance and trends, and facilitates corrective actions as required.… more
- Unither Pharmaceuticals (Rochester, NY)
- …This role is responsible for review and approve a wide variety of GMP related documents and provide appropriate feedback when necessary. This position interacts with ... manager and director levels of management in all departments in developing...meet industry requirements. Provides support during customer and regulatory inspections . Ensures Quality Metrics are delivered. Supervisor's observation: Annual… more
- Nestle (Holbrook, NY)
- …skills + Proven ability to manage of Quality Systems. + Knowledge of regulatory and GMP compliance requirements such as 21 CFR Part 111, HACCP, HARPC preferred + ... nutrition for patients and consumers. **POSITION SUMMARY** Under the direction of the Director Quality, the Manager Facility Quality is responsible for ensuring the … more