Alice Yee
Executive Director, Biologics Quality Control
- Role
- Executive Director, Quality Site Head Biologics Foster City at Gilead Sciences
- Location
- Daly City, CA, US
- LinkedIn followers
- 500 followers
About Alice Yee
16 years of quality experience (QC and QA) with 9 years of supervisory experience of which 16 years is in a GMP environment. • Understand overall end-to-end (cell culture to finish goods) quality issues with program/product which include defining in-process and release control system strategy. • Successfully supported Breakthrough Therapy (BTD) and PRIoity MEdicines (PRIME) designation program that was accelerated by 3 years and received FDA approval two months ahead of PDUFA date with minimal information requests.• Experienced in supporting a post-launch program that has received BLA and MAA approval with a very active clinical program (100+ clinical trials). • Experienced in a GMP Quality Control environment, testing and release of bulk and final products; writing SOPs, WIs, and protocols; knowledgeable of analytical method troubleshooting (CAPA, discrepancies), re-development, validation and lifecycle management; experienced with regulatory submission requirements (PMP’s, CBE’s, IND, Q&A) in support of analytical methods, validation, batch analysis and stability.• Excellent understanding of ICH and compendia (USP, EU and JP) requirements.
Experience
Executive Director, Quality Site Head Biologics Foster City
Nov 2025 — Present
Education
San Francisco State University
MA, Kinesiology
University of Southern California
Ph.D., Kinesiology
Occidental College
B.A, Economics
Skills
- Biotechnology
- Assay Development
- Analytical Chemistry
- Corrective and Preventive Action (Capa)
- Biopharmaceuticals
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