Steven R. Mendivil, BS Amgen Inc.

Steven Mendivil is currently a part time contractor and Senior Advisor for Amgen in International Quality. He had been with Amgen for 19 years and was Executive Director of International Quality, External Affairs. He was previously head of Corporate Quality GMP & EHS and was on the ICH Q11 Expert Working Group and on the ICH Q7 Implementation Working Group. Prior to Amgen, Steve worked for 5 years at Genentech in Quality and 10 years at Syntex in Regulatory Affairs, Quality and Manufacturing. Steve also consults for a number of companies.

He was on the PDA Board of Directors as an Executive Officer and has led various external committees on GMP related topics. Steve is currently PDA’s Quality Metric /Culture Task Force leader.

He has also taught at UC Berkley extension course on Biotechnology and at USC graduate school for Regulatory Affairs.

Steve holds a BS from University of California at Davis and is Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professional Society.