Michelle Frame
Vice President, CMC Project Advisor
- Role
- Vice President, Cmc Project Advisor at Lundbeck
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
About Michelle Frame
Strategic leader with broad experience managing Quality functions. Over 30 years of industry experience in Quality (Quality Assurance and Quality Control) including 20+ years in supervisory roles. Extensive experience managing Quality Systems, Lot Release, CMO Oversight, Audits, Validation, QC and Regulatory CMC Submissions (IND, CTA, MAA and BLAs). Hosted regulatory inspections (FDA, EMA, Health Canada) and formulated responses. Successful record of building teams, managing organizational change and remediating compliance risks. Particular strengths in implementing Quality Systems to meet phase-appropriate business needs.
Experience
Vice President, Cmc Project Advisor
Feb 2023 — Present · US
Education
San Francisco State University
Bachelor of Science - BS, Biochemistry
University of California, Berkeley
Biochemistry
Skills
- Quality Control
- Gmp
- V&V
- Glp
- Clinical Trials
- Computer System Validation
- Pharmaceutical Industry
- Sop
- Fda
- Biotechnology
- Lims
- Gxp
- Change Control
- Capa
- Validation
- Life Sciences
- 21 Cfr Part 11
- Quality Assurance
- Technology Transfer
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