Joann Yates
RETIRED - Sr. Technical Regulatory Program Director at Genentech
- Role
- Sr Technical Regulatory Program Director at Genentech
- Location
- Portland, OR, US
- LinkedIn followers
- 500 followers
About Joann Yates
Experienced Technical Regulatory Program Director with a demonstrated history of working in the biotechnology industry. Skilled in U.S. Food and Drug Administration (FDA), Corrective and Preventive Action (CAPA), Process Engineering, Computer System Validation, and Change Control. Strong program and project management professional with a Bachelor of Science (BS) and Masters of Science (MS) focused in Engineering from Columbia University in the City of New York.
Experience
Sr Technical Regulatory Program Director
Oct 2017 — Present · Hillsboro, OR, US
Education
Columbia University
Master of Science (MS), Engineering
1980 — 1982
Columbia University
Bachelor of Science (BS), Engineering
1979 — 1980
The University of the South
Bachelor of Science - BS, Mathematics
1975 — 1980
Skills
- 21 Cfr Part 11
- Biopharmaceuticals
- Gmp
- Quality Assurance
- Technology Transfer
- Process Improvement
- Quality System
- Computer System Validation
- Change Control
- Automation
- Pharmaceutical Industry
- Sop
- Fda
- Gamp
- Professional Mentoring
- Project Management
- Biotechnology
- Process Engineering
- Capa
- Cross-Functional Team Leadership
- Validation
- Gxp
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