David Hooi
Quality Director | Quality Metrics | Risk Management | Continuous Improvement | Commercial Manufacturing | Collaborator | Compliance Remediator
- Role
- Senior Director Quality at Just - Evotec Biologics
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About David Hooi
Senior-level professional with extensive experience in Biopharma operations (including CMO) and management of GMP Upstream & Downstream mAb production and GMP Gene Therapy. Extensive record of improving efficiency, safety, productivity, quality, and profitability through automation, operation, and process improvements. Experienced in facility design, commissioning, start-up, and validation. Development and implementation of Quality systems for both integrated pharma company as well as a start-up. Completed successful Pre-Approval Inspections (PAIs) for biologics and small molecule products. Outstanding interpersonal, motivational, and presentation skills.
Experience
Senior Director Quality
Oct 2023 — Present · Redmond, WA, US
Education
Thornridge High School
High School
University of Illinois Urbana-Champaign
Bachelor of Science - BS
Cal State East Bay- College of Business & Economics
Master of Business Administration - MBA
Skills
- Biopharmaceuticals
- Quality System
- V&V
- Biotechnology
- Cell Culture
- Clinical Research
- Capa
- Pharmaceutical Industry
- Sop
- Fda
- Glp
- Change Control
- Validation
- Gxp
- Gmp
- Vaccines
- Process Improvement
- Technology Transfer
- 21 Cfr Part 11
- Aseptic Technique
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