Haihong Bao
- Role
- Senior Qa Manager at Gilead Sciences
- Location
- Fremont, CA, US
- LinkedIn followers
- 500 followers
About Haihong Bao
More than 20-year QA (GLP/GCLP/GMP) experience in CxO and biotechnology/pharmaceutical…
Experience
Senior Qa Manager
Jan 2017 — Present
Provide QA oversight of CxO to ensure quality and compliance is maintained for clinical/commercial products, support quality initiatives and responsible for quality metrics, trend reviews, and risk assessments, QAG review. • Represent QA on Materials Review Boards, quality event escalation meetings, and effectively communicates and escalates major and/or critical events to upper management in a timely manner • Review/approve laboratory exception events (e.g. investigations, deviations, CAPA), change control, • Ensure QA oversight and guidance to stability programs across the global network. • Act as a QA subject matter expert in support of regulatory PAI inspections and supplier audits • Provide quality oversight to CMC operations, support regulatory fillings • Review and approve manufacturing records and lot release/disposition
Skills
- Glp
- Pharmaceutical Industry
- Drug Development
- 21 Cfr Part 11
- Capa
- Clinical Development
- Quality Assurance
- Regulatory Affairs
- Gcp
- Sop
- Lifesciences
- R&D
- Ind
- Gmp
- CRO
- Regulatory Submissions
- Validation
- Fda
- Analytical Chemistry
- Drug Discovery
- Biotechnology
- Toxicology
- Hplc
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