Steve is the Director of the Center for Drug Evaluation and Research’s (CDER) Office of Manufacturing and Product Quality (OMPQ) within the Office of Compliance (OC). In this role, he oversees the FDA’s pharmaceutical Current Good Manufacturing Practice (CGMP) office and works closely with other Center and Agency counterparts to assure that safe and effective drugs are available to the American public. As the Director, Steve directs four major compliance divisions: the Division of Domestic Drug Quality (DDDQ), the Division of International Drug Quality (DIDQ), the Division of Good Manufacturing Practice Assessment (DGMPA) and the Division of Policy, Collaboration and Data Operations (DPCDO).
For the first part of 2013 Steve served in two detail/acting roles in FDA’s 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 lead 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.
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.