Joseph Famulare is Vice President - Global Quality Compliance and External Collaboration at Genentech where he is integral in aligning industry and international regulatory authorities around policy and harmonization, and also heads the company’s inspection readiness, GMP auditing and is integral to determining the company’s compliance strategies, among other duties. Joe Famulare joined Genentech in 2009 as the Senior Director of Genentech’s Quality and Compliance External Collaboration function after a 32 year career at FDA. He is the former Deputy Director, CDER Office of Compliance, FDA, where he led an extensive team heading GMP GCP, and GLP Compliance programs. He was a founding member and served on the Council of Pharmaceutical Quality. He also held a number of progressive roles at FDA throughout years of public service. As a Member of ISPE for more than 15 years, Joe Famulare presently serves as a member of the CGMP Executive Planning Committee; Chair of ISPE’s PQLI Initiative, serves on the ISPE Regulatory Compliance Committee and is active in ISPE global activities as a speaker and panelist, most recently in ISPE events in Japan and China. He is a member of the International Leadership Forum (ILF). He was elected to the ISPE International Board of Directors in 2010. Joe Famulare has a BS in Biology in Environmental Studies from St. John’s University and extensive training in manufacturing, microbiological and chemistry, regulatory risk management and leadership.