Paula Lee Email & Phone Number
Independent QA Consultant
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Paula Lee Location
- Boston, MA, US
Paula Lee Work
- Independent QA Consultant @ Biotech and pharmaceutical (March 2025 - Present)
- Associate Director, GMP QA (Commercial Operations) @ (November 2023 - October 2024)
- Sr Manager, GMP QA (Clinical Development and Commercial Operations) @ (September 2020 - November 2023)
- Principal GMP Quality Manager (Clinical Development) @ (February 2019 - September 2020)
- GMP Quality Manager (Clinical Development) @ (August 2014 - January 2019)
- Quality Assurance Consultant @ Genzyme Allston, MA Facility (April 2013 - July 2014)
- QA Manager, Corporate QA (Global QMS and Document Control) @ (July 2008 - February 2013)
- Manager, Product Quality Assurance and Late Phase Clinical Development @ (March 2007 - June 2008)
- QA Production Support Manager and Commercial @ (April 2001 - April 2007)
Paula Lee Education
- Northeastern University
Master of Science (M.S) (Regulatory Affairs for Drugs, Biologics, and Medical Devices)
- Sweet Briar College
Bachelor's degree (Chemistry/physics (minor))
Paula Lee Skills
- 21 CFR Part 11
- Biopharmaceuticals
- Biotechnology
- CAPA
- Change Control
- Continuous Improvement
- Cross-functional Team Leadership
- Document Management
- Drug Development
- FDA
- GMP
- Good Clinical Practice (GCP)
- GxP
- Life Sciences
- Management
- Medical Devices
- Pharmaceutical Industry
- Project Management
- Quality Assurance
- Quality Auditing
- Quality System
- SOP
- Validation
- Leadership
- Test Planning
- Good Clinical Practice Gcp
- Microsoft Office
- Microsoft Excel
- Cross Functional Team Leadership
- SQL
- Good Clinical Practice
Paula Lee Summary
- Paula Lee, based in Boston, MA, US, is currently a Independent QA Consultant at Biotech and pharmaceutical. Paula Lee brings experience from previous roles at Sage Therapeutics and Takeda Oncology. Paula Lee holds a Master of Science (M.S) in Regulatory Affairs for Drugs, Biologics, and Medical Devices @ Northeastern University. With a robust skill set that includes 21 CFR Part 11, Biopharmaceuticals, Biotechnology, CAPA, Change Control and more. Paula Lee has 1 emails and 1 mobile phone numbers on RocketReach.
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