Kay Debroux
- Role
- Quality Product Steward at Bayer
- Location
- Los Angeles, CA, US
- LinkedIn followers
- 500 followers
About Kay Debroux
A successful Pharmaceutical Quality Assurance Leader with a demonstrated history of…
Experience
Quality Product Steward
Jun 2020 — Present
Support Bayer’s expansion into Cell and Gene Therapies by providing Quality subject matter expertise to identify gaps in existing processes for raw material / vendor selection, QC analytics, method validation, and manufacturing / process development for Cell and Gene therapy manufacturing product platforms and work with respective teams to develop solutions
Education
Questrom School of Business, Boston University
MS, Project Management
2006 — 2008
Nassau Community College
AAS, •Medical Laboratory Technology
1987 — 1989
University of Hawaii at Manoa
BA, Philosophy
1980 — 1982
Skills
- Regulatory Submissions
- Clinical Trials
- Sop
- Life Sciences
- Standard Operating Procedure (Sop)
- Computer System Validation
- Glp
- Technology Transfer
- Process Simulation
- Gxp
- V&V
- Quality Systems
- Quality Control
- Lifesciences
- Quality Assurance
- Regulatory Affairs
- Capa
- Validation
- Quality System
- 21 Cfr Part 11
- Cell Culture
- Vaccines
- Change Control
- Biotechnology
- Verification and Validation (V&V)
- Chromatography
- Purification
- U.s. Food and Drug Administration (Fda)
- Gmp
- Drug Development
- Management
- Cross-Functional Team Leadership
- Microbiology
- Fda
- Project Management
- Lims
- Corrective and Preventive Action (Capa)
- Biopharmaceuticals
- Laboratory
- Manufacturing
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