Steven Lynn
EVP, Pharma and Biologics
Regulatory Compliance Associates
Steven Lynn, executive vice president (EVP) of pharmaceuticals for Regulatory Compliance Associates (RCA), has more than 26 years of quality and regulatory compliance-related experience in the pharmaceutical, biopharmaceutical, medical device, blood, plasma and tissue industries. Joining RCA in September 2020, Steven serves as EVP of pharmaceuticals and biologics. Prior to joining RCA, he served in executive leadership and board of director level roles with global accountability in the private sector as well as at the FDA. While at the agency, he was the director of CDER’s Office of Manufacturing and Product Quality (aka drug CGMP compliance office). In this role, he was responsible for the global CGMP compliance oversight of all drugs manufactured and/or imported into the U.S. In addition, in his last year at the FDA, he also served as the operations transition lead responsible for collaboratively establishing the operations functions for CDER’s Office of Pharmaceutical Quality (OPQ).
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