Maggie Chen Email & Phone Number
Head Global Quality Systems @ Simtra BioPharma Solutions
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Maggie Chen Location
- United States
Maggie Chen Work
- 2025 -now Head Global Quality Systems @
- 2023 -2024 Senior Vice President, Site Head @
- 2021 -2023 Sr. Director, Manufacturing (CGT ), Interim Eng Head for CGT and Biologics @
- 2019 -2021 Director, Global Head of Validation; Head of Engineering, Longmont Site @
- 2018 -2019 Interim Assignment - MST @
- 2014 -2016 Sr. Product Steward, MS and T @
- 2011 -2014 Sr Quality Engineer Lead @
- 2002 -2009 Manufacturing Engineering Project Manager and Validation Specialist @
- 1998 -2001 Project Manager @
- 2016 -2019 Associate Director, MS and T @
- 2009 -2011 Quality Computer and Software Validation Lead @ Spectranetics (now Philips)
Maggie Chen Education
- University of Colorado Denver
- Xi'an Jiaotong University
Maggie Chen Skills
- Validation
- CAPA
- Cross-functional Team Leadership
- Technology Transfer
- 21 CFR Part 11
- V&V
- Process Improvement
- FDA
- Regulatory Affairs
- Quality System
- Sop
- Quality Assurance
- GMP
- Quality Auditing
- Medical Devices
- Pharmaceutical Industry
- Change Control
- GxP
- ISO 13485
- Computer System Validation
- Corrective and Preventive Action (CAPA)
- GAMP
- Manufacturing
- Standard Operating Procedure (SOP)
- U.S. Title 21 CFR Part 11 Regulation
- U.S. Food and Drug Administration (FDA)
- Verification and Validation (V&V)
- Aseptic Processing
- Cleaning Validation
- GLP
Maggie Chen Summary
- Maggie Chen, based in United States, is currently a Head Global Quality Systems at Simtra BioPharma Solutions. Maggie Chen brings experience from previous roles at KBI Biopharma, AGC Biologics and Novartis Gene Therapies. Maggie Chen holds a University of Colorado Denver. With a robust skill set that includes Validation, CAPA, Cross-functional Team Leadership, Technology Transfer, 21 CFR Part 11 and more. Maggie Chen has 1 emails and 1 mobile phone numbers on RocketReach.
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