George Willis
Director Clinical Operations at Bristol Myers Squibb
- Role
- Director Clinical Operations at Bristol Myers Squibb
- Location
- New Brunswick, NJ, US
- LinkedIn followers
- 500 followers
About George Willis
A strong leader with 35+ years of Pharmaceutical industry experience in R&D and GMP Operations. Expertise: Clinical Research, Electronic Batch Record design and implementation, Regulatory Inspections & Inspection Readiness (IRIS), Standard Operating Procedures (SOPs) Development/ Review / Implementation; Manufacturing Systems Design, Facilities Management, Capital Budget Planning, Process Improvement Plans etc; Proven track record in establishing Standard Operating Procedure SOP processes to enhance productivity across various departments including Engineering-Maintenance/Management functions and Business Administration which resulted in significant cost reductions. Experience in negotiating labor contracts and conflict resolution.Responsible for global operations (US and UK) oversight. Device (combo drug) assembly (autoinjector & passive safety device) experience. Proven track record managing internal operations responsible for producing clinical supplies supporting Phase 1-4 of drug development.
Experience
Director Clinical Operations
Oct 2020 — Present · US
Education
Wagner College
BS, Microbiology and Public health
1980 — 1984
Skills
- U.s. Food and Drug Administration (Fda)
- Manufacturing
- Glp
- Oncology
- Regulatory Submissions
- Pharmaceutics
- Regulatory Affairs
- Lifesciences
- Ctms
- Clinical Trials
- Technology Transfer
- 21 Cfr Part 11
- Medical Devices
- Clinical Research
- Capa
- Gmp
- Good Clinical Practice (Gcp)
- Life Sciences
- CRO
- Biotechnology
- U.s. Title 21 Cfr Part 11 Regulation
- Pharmaceutical Industry
- Sop
- Fda
- Regulatory Requirements
- Management
- Drug Development
- Quality System
- Gcp
- Biopharmaceuticals
- Standard Operating Procedure (Sop)
- Corrective and Preventive Action (Capa)
- CRO Management
- Cross-Functional Team Leadership
- Clinical Development
- Validation
- Change Control
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