Stephen Mahoney is 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. 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 regulatory and enforcement actions involving adulterated and misbranded drug products. After law school, Stephen practiced pharmaceutical and biotechnology law at a large international law firm in Washington, DC.
Stephen was elected to the ISPE International Board of Directors in 2019-2021. He also has served on the ISPE Drug Shortage Working Group since its inception in 2012. More recently, Stephen has served on several ISPE conference committees.
Stephen is a member of PhRMA’s Global Quality and Manufacturing Work Group, where he is representing PhRMA at the International Conference on Harmonization (ICH) as part of the Q9 Expert Working Group (EWG). He also is a member of Biotechnology Industry Organization (BIO)’s Manufacturing Committee. He previously has represented BIO at the International Conference on Harmonization (ICH) as part of the Q7 Implementation Working Group (IWG). 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.