Steven J. Lynn, MS

Executive Principal Consultant, Pharma and Biologics

 

FDA Consultant

 

Steve has over 25 years of quality and regulatory compliance related experience in the pharmaceutical, biopharmaceutical, medical device, blood, plasma and tissue industries. He served in executive leadership roles with global accountability in both the private sector, as well as at the US FDA.

Steve is an expert in Current Good Manufacturing Practices (CGMP) compliance related matters and has significant experience with other GxP quality compliance and regulatory issues (Ex: GCP and PV).

Steve is currently the Executive Principal Consultant, Pharmaceuticals and Biologics for Regulatory Compliance Associates (RCA). Prior to RCA he was the principal consultant/owner for Lynn Consulting, LLC, which provided expert GxP consulting services to the life sciences industry.

Before entering the consulting world, Steve was the Global Head of Group (Corporate) Compliance and Audit at Novartis AG. In this role Steve led the corporate compliance and audit functions for Novartis. Prior to joining Novartis, Steve was the inaugural Vice President of Global Quality Compliance at Mylan, Inc. in Canonsburg, PA.

 

FDA Compliance Consultant

 

Prior to Mylan, Steve was the Director of the FDA Center for Drug Evaluation and Research (CDER) Office of Manufacturing and Product Quality (OMPQ) within the Office of Compliance (OC). In this role he was responsible for the global Current Good Manufacturing Practices (CGMP) oversight of all drugs manufactured and/or imported into the United States to assure compliance with CGMPs. In addition, in his last year at the FDA he served in a dual position as the Operations Transition Lead for CDER’s new Office of Pharmaceutical Quality (OPQ) reporting to CDER’s Center Director where he was responsible for setting up OPQ operations.

Steve also served in two acting roles on the inspectorate side of FDA within the Office of Regulatory Affairs (ORA). First, he served as the acting Senior Advisor to the Assistant Commissioner for Operations (ACO) within the Immediate Office of ORA’s Office of Operations. In this role, Steve was responsible for advising the ACO in their role of leading and managing ORA’s Office of Operations, which is responsible for all of the Agency’s Headquarters, Domestic and Foreign Field Investigatory, Compliance and Laboratory Operations. Second, Steve served as the acting Director for ORA’s Office of Medical Products and Tobacco Operations (OMPTO).

In this role, Steve represented and made decisions on behalf of the ACO relating to medical and tobacco product program investigatory operational issues, including emergency response activities. In addition, he directed the coordination and management of all domestic and foreign Agency field operations related to medical (drugs, biologics and medical devices) and tobacco products and served as the operational liaison for medical products and tobacco inspection programs to FDA’s medical product and tobacco Centers, as well as to the Agency’s foreign offices.

Before re-joining CDER, Steve served as the Lead Quality System Manager in the Immediate Office of the Associate Commissioner for Regulatory Affairs (ACRA) in ORA. In this position he led a group of 50+ quality system managers (QSMs) in the planning, development and implementation of ORA’s inaugural (and the Agency’s first) organization-wide formal Quality Management System.

 

FDA Consulting Services

 

Steve received a Bachelor of Science degree in Biology from Bethany College in Bethany, WV, and a Master of Science Degree in Quality Systems Management from the National Graduate School in Falmouth, MA. He is an Eagle Scout, Senior Member of the American Society for Quality (ASQ) and an Excellence in Government Program Senior Fellow.