2022 -
2024 Associate Director, R and D Strategy, Governance, and Quality - Functional Quality Lead @
2017 -
2022 Associate Director, Research and Development Quality and Compliance - Audit @
2017 -
2017 Laboratory Quality and Compliance Consultant @
2016 -
2017 Director Of Quality @ Court Square Group, Inc.
2015 -
2016 Quality Manager @ Cambridge Biomedical Inc.
2015 -
2015 Laboratory Manager @ Cambridge Biomedical Inc.
2012 -
2015 Quality Systems Manager @ Cambridge Biomedical Inc.
2011 -
2011 QA Documentation Specialist and Technical Writer @
2005 -
2009 Corporate Quality Documentation @
Heather Lee Education
Northeastern University 2017
-
2019
Suffolk University 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 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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