Amy Stanton MBA Amgen

Amy Stanton joined Amgen in 2003 in Thousand Oaks, CA. During her time at Amgen, she has held multiple positions within the Amgen Corporate Quality Compliance Department and External Affairs. Amy helped develop and support the GxP Intelligence Program and the Compliance Intelligence Program at Amgen and continues to enhance and manage the program over the years. She also co-founded the Regulatory Intelligence Discussion Group (RIDG), establishing a group of industry representatives to share and benchmark intelligence information and requirements. As Vice Chair of Amgen’s RIVER (Recognition of Indigenous People, Values & Environmental Resources), she looks to connect the business to the current and historical importance of Indigenous Peoples. Previously Amy was the Project Manager for the PDA Technical Report No. 74 on Reprocessing of Biopharmaceuticals and PDA Technical Report No. 85 Enhanced Test Methods for Visible Particle Detection and Enumeration on Elastomeric Closures and Glass Containers. Currently Amy is Rapporteur Supporter/Content Manager for the ICH Q3E Guideline on Extractables and Leachables. Amy currently sits on the Board for PDA Southern California as President Elect and in January 2025 will step into the role of President. Amy holds a BS in Business Management and an MBA from California Lutheran University.