Shawn Gould
- Role
- Director, J & J Regulatory Compliance at Johnson & Johnson
- Location
- Brighton, MI, US
- LinkedIn followers
- 500 followers
Healthcare & Human ServicesView LinkedIn profile
Experience
Director, J & J Regulatory Compliance
Aug 2016 — Present
Ensure pharmaceutical manufacturing sites maintain a state of compliance with pertinent statutes and regulations.
Education
The University of Toledo
BS, Chemical Engineering
1989 — 1995
Washington University in St. Louis
MS, Chemical Engineering
1995 — 1998
Skills
- Drug Development
- Computer System Validation
- Lifesciences
- Quality Assurance
- Manufacturing
- Pharmaceutical Industry
- Biopharmaceuticals
- Regulatory Submissions
- Quality Auditing
- Biotechnology
- Gxp
- Regulatory Affairs
- Formulation
- Glp
- Quality System
- Hplc
- Root Cause Analysis
- Change Control
- R&D
- Quality Management
- Iso 13485
- Capa
- Fda
- Compliance
- V&V
- Technology Transfer
- Sop
- Validation
- Cgmp Manufacturing
- Quality by Design
- Medical Devices
- Aseptic Processing
- Vaccines
- Process Simulation
- Quality Control
- Ind
- Cgmp Practices
- Gmp
- Cleaning Validation
- Chromatography
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