Dave Henderson
Vice President, Quality Assurance at Oakwood Labs
- Role
- Vice President, Quality Assurance at Oakwood Labs
- Location
- Bedford, OH, US
- LinkedIn followers
- 500 followers
About Dave Henderson
Twenty six years of experience in aseptic manufacturing with twenty years of progressive management experience in the pharmaceutical industry,Comprehensive exposure to global regulatory agencies with significant regulatory inspection experience.Experience with aseptic manufacturing of various product formulations in an array of profiles. Strong customer service experience in a contract manufacturing environment.
Experience
Vice President, Quality Assurance
Mar 2021 — Present
Responsible for quality oversight for the site. Responsible for Quality Control Chemistry, Microbiology, Validation, Quality Assurance, and Technology Transfer departments. Managed a team of 5 direct reports and 35 indirect reports.
Education
University of Akron
Bachelor's degree, Supply Chain and Operations Management
1998 — 2007
Skills
- Validation
- Quality System
- V&V
- Regulatory Requirements
- Root Cause Analysis
- Clinical Trials
- Pharmaceutics
- 21 Cfr Part 11
- Trackwise
- Glp
- Medical Devices
- Capa
- Biopharmaceuticals
- Regulatory Affairs
- Lifesciences
- Gxp
- Aseptic Processing
- Life Sciences
- Gmp
- Change Management
- Change Control
- Process Improvement
- Technology Transfer
- Manufacturing
- Formulation
- Iso
- Pharmaceutical Industry
- Sop
- Fda
- Lyophilization
- Cross-Functional Team Leadership
- Project Management
- Biotechnology
- Cleaning Validation
- Quality Assurance
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