Alexander Tung
Vice President Quality Assurance at AN2 Therapeutics
- Role
- Vice President Quality Assurance at An2 Therapeutics
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Alexander Tung
Results-driven, versatile leader with demonstrated experience and understanding of FDA, EMA, EU Qualified Person and Health Canada regulations and requirements in support of QA, CMC and non-clinical related activities. Extensive experience implementing and managing phase appropriate Quality Management systems, document management, vendor qualification and auditing. Skilled at managing multiple priorities in a fast-paced, multidisciplinary team environment. Managed, mentored and contributed to the professional development of junior staff.Core Competencies:• Quality Management Systems and Processes • Vendor Qualification, Management and Oversight• Documentation Management • Risk Management • Validation • Controlled Drug Substances• PAI Readiness | Regulatory/Client Inspections • Validated Electronic Systems • Class A MRP II • Project Management• Written and verbal communication; problem solving skills
Experience
Vice President Quality Assurance
May 2022 — Present · Menlo Park, CA, US
Education
Wilfrid Laurier University
B.Sc., Chemistry
1989 — 1993
Seneca Polytechnic
Certificate, Industrial Pharmaceutical Technology
1994 — 1995
Seneca Polytechnic
Certificate, Quality Assurance
1996 — 1998
Skills
- Glp
- Quality Assurance
- 21 Cfr Part 11
- Capa
- Quality System
- Quality Control
- Gmp
- Biotechnology
- Gxp
- Quality Auditing
- Change Control
- Validation
- Pharmaceutical Industry
- Sop
- Fda
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