Heather Lee Email & Phone Number
Director, Quality Management @ Biogen
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Heather Lee Location
- Cambridge, MA, US
Heather Lee Work
- Director, Quality Management @ (July 2024 - Present)
- Associate Director, R and D Strategy, Governance, and Quality - Functional Quality Lead @ (April 2022 - July 2024)
- Associate Director, Research and Development Quality and Compliance - Audit @ (November 2017 - April 2022)
- Laboratory Quality and Compliance Consultant @ (April 2017 - November 2017)
- Director Of Quality @ Court Square Group, Inc. (April 2016 - April 2017)
- Quality Manager @ Cambridge Biomedical Inc. (October 2015 - April 2016)
- Laboratory Manager @ Cambridge Biomedical Inc. (June 2015 - October 2015)
- Quality Systems Manager @ Cambridge Biomedical Inc. (September 2012 - July 2015)
- QA Documentation Specialist and Technical Writer @ (January 2011 - January 2011)
- Corporate Quality Documentation @ (October 2005 - January 2009)
Heather Lee Education
- Northeastern University
Master's degree (Regulatory Affairs for Drugs, Biologics and Medical Devices)
2017-2019 - Suffolk University
Bachelor's degree (English, Art History)
1998-2003
Heather Lee Skills
- Quality Assurance
- 21 CFR Part 11
- Quality System
- FDA
- Software Documentation
- Biotechnology
- Validation
- GMP
- GLP
- Computer System Validation
- SOP
- GxP
- Change Control
- CAPA
- GCP
- Regulatory Affairs
- Cross-functional Team Leadership
- LIMS
- GCLP
- Equipment Qualification
- Training
- Risk Assessment
- Risk Management
- Analytical Method Validation
- Quality Auditing
- Microsoft Word
- SharePoint
- Good Laboratory Practice Glp
- Running Errands
- Cross Functional Team Leadership
- u.s. Food and Drug Administration Fda
- Standard Operating Procedure Sop
- Dump Truck
- Laboratory
- Cross Functional Team
- Testing
- Computer System
- Standard Operating Procedure
- u.s. Food and Drug Administration
- Good Laboratory Practice
Heather Lee Summary
- Heather Lee, based in Cambridge, MA, US, is currently a Director, Quality Management at Biogen. Heather Lee brings experience from previous roles at Biogen, Sarepta Therapeutics and Court Square Group, Inc.. Heather Lee holds a 2017 - 2019 Master's degree in Regulatory Affairs for Drugs, Biologics and Medical Devices @ Northeastern University. With a robust skill set that includes Quality Assurance, 21 CFR Part 11, Quality System, FDA, Software Documentation and more. Heather Lee has 2 emails and 2 mobile phone numbers on RocketReach.
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