Stephen Mahoney is a Senior Director in Global Quality and Compliance at Genentech, Inc. In this role, he advises senior leaders on cross-brand regulatory and manufacturing Quality matters. Stephen is a member of the ISPE Regulatory Compliance Committee (RCC) and serves on the ISPE Drug Shortage Working Group. Stephen also is a member of the Biotechnology Industry Organization (BIO)’s Manufacturing Committee, currently representing BIO at the ICH Q7 Implementation Working Group (IWG). Previously, Stephen served as a Compliance Officer in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). In that capacity, he helped develop guidance and policy related to the current good manufacturing practice regulations and managed agency advisory actions enforcement actions involving adulterated and misbranded drug products. After law school, Stephen practiced pharmaceutical and biotechnology law at Hogan Lovells (formerly Hogan and Hartson) in Washington, DC. Stephen received his BA in Biology from the College of the Holy Cross, his MS in Biotechnology from Johns Hopkins University, and his JD from Georgetown University.