- ICON Clinical Research (Blue Bell, PA)
- …medical monitors, as well as staff from quality, clinical compliance, regulatory , formulations, and IOPS ( CMC , external manufacturing, stability). Vendor ... Clinical Drug Supply Manager ICON plc is a world-leading healthcare intelligence...needed. Supports inspection team in preparation for and during regulatory agency inspection. Study Team Interaction + Represents Clinical… more
- Bristol Myers Squibb (Devens, MA)
- … CMC deliverables, technical team objectives, life-cycle improvements, and regulatory commitments. + Provides technical quality expertise and compliance oversight ... the commercial program (vector, gene editing and cell therapy projects) to ensure regulatory compliance of GMP operations in support of the program.The PQL must… more
- AbbVie (Irvine, CA)
- …(Development, Discovery, Development Sciences, Operations, Commercial, Market Access, Regulatory , Safety, Project Management, Medical Affairs, etc., and substantial ... project's primary point of contact for Pipeline Governance and senior management. + Has a broad vision for the...PDP, tracking progress in conjunction with the Portfolio Project Manager , with attention to committed timeline and budget. +… more
- Bristol Myers Squibb (Princeton, NJ)
- …with drug development functions (including Strategy & Portfolio Management, Global Regulatory & Safety, and Global Development Operations), and other functions ... within [Disease Area] + Prioritizes, synthesizes, and pressure tests feedback from senior leadership on program direction/outputs and coaches GPLs in building this… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …Kite's External Quality Organization. The QA Specialist III will report to the Senior Manager , External Quality. Scope of the External Quality group includes ... Analytical Development, Process Development, Quality, Manufacturing, Supply Chain, and Regulatory ) as well as international partners. The ideal candidate will… more
- Integra LifeSciences (Plainsboro, NJ)
- …through Sunday. **SUPERVISION RECEIVED** Under direct supervision of the Senior Manager , Manufacturing. **SUPERVISION EXERCISED** Directly supervises weekend ... Packaging Operations is responsible for the skin packaging production activities for CMC (Collagen Manufacturing Center) to ensure the safety, efficacy, and quality… more