Steve is the currently the acting Senior Advisor to the Assistant Commissioner for Operations (ACO) within the Office of Regulatory Affairs (ORA). In this current role, Steve is 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.
Steve’s permanent job is Director for CDER’s Office of Manufacturing and Product Quality within the Office of Compliance. In this role, he works closely with other Center and Agency counterparts to assure that safe and effective drugs are available to the American public by ensuring that domestic and international drug manufacturers produce high-quality drug products in accordance with current Good Manufacturing Practices (cGMPs). As the Director, Steve directs four major divisions in compliance: 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).
Steve also served on detail in FDA’s Office of the Commissioner/Office of Management on the Agency’s initial round of business process improvement (BPI) projects with McKinsey Corporation and Telesis Corporation. In addition, he worked as an Interdisciplinary Scientist in Risk Management in FDA’s CDRH/OC, where he co-administered the Center’s Risk-Based Work Plan.
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).