Steven Lynn

  PhotoSteve is currently the Global Head of Group (Corporate) Compliance and Audit (GCA) for Novartis. In this role he is responsible for leading and managing Novartis' Group Compliance and Audit (GCA) function within the Group/Corporate Quality Organization. GCA is accountable for supporting the overall quality organization by providing GxP (GMP, GCP, GLP and PV) governance and independent compliance and audit oversight for Novartis. Within GCA, he oversees three separate, but highly interrelated sub-functions: 1. Corporate Compliance; 2. Corporate GxP Audits; and 3. Quality Risk Management (QRM). Prior to joining Novartis Steve was the VP of Global Quality Compliance at Mylan, Inc. In this role Steve was responsible for assessing and monitoring the compliance of Mylan’s processes and products to foster sustainable Good Manufacturing Practice compliance and a continual state of inspection readiness across the globe. His team also managed Mylan’s global escalation process and ensured appropriate, consistent health-authority inspection responses. In addition, the group included a rapidly deployable team of subject matter experts capable of assisting Mylan sites as needed. Prior to joining Mylan in May 2014, Steve was with the Food and Drug Administration for close to 10 years. Prior to leaving the government Steve was the Director of the FDA/Center for Drug Evaluation and Research’s (CDER) Office of Manufacturing and Product Quality (OMPQ) within the Office of Compliance (OC), as well as the Operations Transition Lead for the new Office of Pharmaceutical Quality. During his time at the FDA Steve served in CDRH Compliance, the Office of Regulatory Affairs and CDER in various roles of increasing responsibility and scope. Steve received a Bachelor’s of Science degree in Biology from Bethany College in Bethany, WV, and a Master’s of Science Degree in Quality Systems Management from the National Graduate School in Falmouth, MA. He is a Senior Member of the American Society for Quality (ASQ) and is an Excellence in Government Program Senior Fellow. Steve is also an ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE).