Robert L. Iser, M.S.
Pharma Technical Quality & Compliance (PTQ), Genentech/Roche
Vice President, Quality Policy and Advocacy (VP)
Bob joined Genentech in 2022 as the Lead, Quality Policy and Advocacy, where he champions CGMP Compliance and Sustainability, builds relationships and advocates for Genentech / Roche Industry positions in the area of Quality & Compliance in strategic committees and industry working groups involving and interacting with Health Authorities; and identifies and incorporates emerging regulatory trends impacting quality and CGMP compliance and beyond. Prior to joining Genentech, Bob was SVP, Global Quality Management with Amneal Pharmaceuticals for 2 years with oversight of global quality standards, the quality system policies, and site quality. He spent 2 years at part of the leadership team at Parexel as VP, Regulatory Consulting Services. He spent 14 years at FDA in multiple roles of increasing leadership responsibilities in the Office of Generic Drugs, the Office of Pharmaceutical Sciences and the Office of Pharmaceutical Quality, where his most recent role was Office Director of the Office of Process & Facilities (now OPMA) responsible for the assessment of manufacturing processes, microbiology aspects and pre-approval inspection decisions for ANDAs, NDAs and BLAs. While at FDA, Bob was part of USP and ICH Expert Working groups, including the ICH Q12 EWG. Before joining FDA, Bob worked seven years at Eurand, Inc. (now Aptalis), primarily, in leadership of the Quality Control laboratory. Bob has a Bachelor of Science in Chemistry from Muskingum University and a Master of Science in Chemistry from Wright State University.
