Catherine Watkins
Head of Product Quality
- Role
- Head of Product Quality & Lifecycle Management, Biologics Operating Unit at Takeda
- Location
- Cambridge, MA, US
- LinkedIn followers
- 500 followers
About Catherine Watkins
Accomplished global quality leader with end-to-end experience from discovery through commercialization. I drive strategic quality design across complex, multi-modal portfolios and international supply chains, creating clarity in high-pressure, cross-functional environments.Expertise includes senior leadership in Global Product Quality, Site Quality Head (QA/QC), Validation, Computerized Systems and Automation, Cleaning and Equipment, Sterility Assurance and Aseptic Processes, Quality Systems, Change Management, Risk Management, Design Control, Quality by Design, and Data Integrity.I hold a Master of Science in Bioprocess Engineering and consistently deliver impact through strategic vision, clear communication, and results-focused leadership.
Experience
Head of Product Quality & Lifecycle Management, Biologics Operating Unit
Dec 2025 — Present
Education
SUNY ESF
Master of Science (M.S.), Bioprocess Engineering
2009 — 2011
University of New Hampshire
Bachelor of Science (B.S.), Environmental Science
Skills
- Chromatography
- Cleaning Validation
- Microbiology
- U.s. Title 21 Cfr Part 11 Regulation
- Cell Culture
- Hplc
- U.s. Food and Drug Administration (Fda)
- Standard Operating Procedure (Sop)
- Purification
- Quality Assurance
- R&D
- 21 Cfr Part 11
- Validation
- Change Control
- Pharmaceutical Industry
- Sop
- Fda
- Biotechnology
- Capa
- Biopharmaceuticals
- Gmp
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