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Paula Lee, M.Sc. has extensive experience in the pharmaceutical industry, with a focus on quality assurance. From 2001 to 2007, they worked as a QA Production Support Manager/Commercial at Shire Pharmaceuticals. Following that, they served as Manager, Product Quality Assurance/Late Phase Clinical Development at Alkermes from 2007 to 2008. Subsequently, they worked at Biogen as a QA Manager, Corporate QA (Global QMS/Document Control) from 2008 to 2013. Afterward, they worked as a QA Consultant at Validant for a year. From 2014 to 2020, they held roles of increasing responsibility at Takeda Oncology, starting as a GMP Quality Manager/Clinical Development and eventually becoming a Principal GMP Quality Manager/Clinical Development. Most recently, they joined Sage Therapeutics in 2020 as a Sr Manager, QA Commercial Operations Head.

Paula Lee, M.Sc. obtained a Master of Science (M.S.) degree in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University. Prior to that, they completed their Bachelor's degree (B.A.) in Chemistry/physics from Sweet Briar College. Additionally, Paula has obtained certifications in Biopharmaceutical Domestic Regulatory Affairs and Biopharmaceutical International Regulatory Affairs from Northeastern University.