Steven Lynn, MS Regulatory Compliance Associates Inc.

Steven Lynn has 24 years of quality & regulatory compliance experience in the pharma, biopharma, medical device, and biologics industries. He served <br>in executive leadership roles with global accountability in both the private sector, as well as at the U.S. FDA. Steve is an expert in GxPs. He is currently the Executive VP of Pharmaceuticals at Regulatory Compliance Associates (RCA). Before consulting, Steve was the VP, Global Head of Corporate GxP Compliance & Audit at Novartis AG. Prior to Novartis, Steve was the VP of Global Quality Compliance at Mylan, Inc. Steve also spent nearly a decade at the FDA in roles of increasing responsibility, including the Office Director of the CDER's Office of Manufacturing and Product Quality, where he was responsible for the global CGMP oversight of all drugs manufactured and/or imported into the U.S. Additionally, he was the Operations Transition Lead for CDER’s Office of Pharmaceutical Quality reporting to CDER’s Center Director where he was responsible for setting up OPQ operations. Steve has a BS in Biology and a MS in Quality Systems Management. He is an Eagle Scout, Senior Member of the American Society for Quality and an Excellence in Government Program Senior Fellow.