Joseph C. Famulare
Famulare Consulting LLC
Principal
Joseph Famulare is Vice President - Global Quality Compliance and External Collaboration at Genentech/Roche, Pharma Technical Operations. He is active 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. Mr. 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, he has led ISPE’s PQLI® Initiative, serves on the Regulatory Compliance Committee and Drug Shortages and Quality Metrics Initiatives. He is active in ISPE global activities as a speaker and panelist, chaired the 2013 ISPE Pharmaceutical Quality System (ICH Q10) Conference in China and has co-chaired successive ISPE/FDA co-sponsored conferences over the past 5 years. Mr. Famulare has actively participated on the Global Pharmaceutical Manufacturing Leadership Forum (GPMLF). He recently co-led the publication of PQLI®'s Quality System Guideline on Process Performance and Product Quality Monitoring. He currently serves as the Chair of the ISPE International Board of Directors. Mr. Famulare has a BS in Biology and Environmental Studies from St. John's University and extensive training in manufacturing, microbiology and chemistry, regulatory risk management and leadership.
