- Regeneron Pharmaceuticals (Armonk, NY)
- …with other department leaders for effective quality oversight. + Represent senior management at quality forums and during regulatory inspections. **This Role ... May Be for You If You:** + Have strategic leadership and technical expertise in the Quality Management System Framework, Quality Vault, Computer System Validation (CSV), and Quality Standards. + Can act as the primary Business Process Owner and Subject Matter… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …Lead (IML) is a key position that is responsible for the effective management of GCP , GVP and GLP inspections. The GDQIM IML will engage with key stakeholders, ... The Associate Director , Global Development Quality Inspection Management (GDQIM) acting...if have:** * Advanced knowledge, understanding and application of GCP , and/or GVP guidelines including the management… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …for the successful oversight and completion of a broad spectrum of GCP audit activities and deliverables across large sites, countries, or multiple regions. ... as a primary point-of-contact to assigned R&D groups and advise on: GCP regulatory requirements; relevant Gilead policies and procedures supporting audits and… more
- Ascendis Pharma (Palo Alto, CA)
- …activities in Ascendis. Key Responsibilities Pharmacovigilance related responsibilities over GVP , Patient Support Programs (PSPs) and other Service Providers (SPs) ... with functional partners / vendors as required. + Monitoring GVP and PSP SPs to identify areas of risk...of CAPAs as necessary + Work Closely with Ascendis GCP /PV Compliance team and Commercial organization as required to… more
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