Maggie Chen Email & Phone Number
Head Global Quality Systems @ Simtra BioPharma Solutions
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Maggie Chen Location
- United States
Maggie Chen Work
- Head Global Quality Systems @ (March 2025 - Present)
- Senior Vice President, Site Head @ (November 2023 - November 2024)
- Sr. Director, Manufacturing (CGT ), Interim Eng Head for CGT and Biologics @ (September 2021 - October 2023)
- Director, Global Head of Validation; Head of Engineering, Longmont Site @ (September 2019 - September 2021)
- Interim Assignment - MST @ (January 2018 - September 2019)
- Sr. Product Steward, MS and T @ (January 2014 - January 2016)
- Sr Quality Engineer Lead @ (January 2011 - January 2014)
- Manufacturing Engineering Project Manager and Validation Specialist @ (January 2002 - January 2009)
- Project Manager @ (January 1998 - January 2001)
- Associate Director, MS and T @ (January 2016 - January 2019)
- Quality Computer and Software Validation Lead @ Spectranetics (now Philips) (January 2009 - January 2011)
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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Top Simtra BioPharma Solutions Employees
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Atlanta, GA, US
Ray Guidotti
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Cary, NC, US
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John Upperman
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John Kyle
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Lidia Serina
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United States
Patrick Adams
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Bloomington, IN, US
Tibor Friedrich
Chief Transformation Officer
Princeton, NJ, US
Rob Perry
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Cary, NC, US
Gregory Ogburn
Vice President Finance
Atlanta, GA, US
Hali Lewis
VP, Global Controller
Charlotte, NC, US
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Mike MacRie
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New York, NY, US
Vivek Seth
VP of Technology
San Jose, CA, US
Bo Watkins
SVP of Sales and Business Management
Columbus, IN, US
Joel Tobin
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Philadelphia, PA, US
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