Amy Stanton Quality Systems Specialist, External Affairs, Amgen, Inc.

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 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. Currently Amy is Rapporteur Supporter/Content Manager for the ICH Q3E Guideline on Extractables and Leachables and Project Manager (PM) for the PDA Visible Particles Team (Technical Report No. 85). Previously Amy was the PM for the PDA Technical Report No. 74 on Reprocessing of Biopharmaceuticals which was published in June 2016. Amy currently sits on the Board for PDA Southern California. Prior to Amgen, Amy worked within the Compliance Department at Intel. Amy holds a BS Business Management and an MBA in Organizational Behavior and Management from California Lutheran University.

In her spare time, Amy volunteers and sits on the Board for Honoring Our Fallen, a non-profit organization dedicated to serving our nation’s fallen and the families these heroes have left behind. She also enjoys spending time with her husband Scott and daughter Scottlyn and loves to stay active playing sports, hiking and working out.

Amy is proud tribal member of the Choctaw Nation of Oklahoma and is proud to share with friends, family and those who want to learn more about the traditions and culture so that it continues to live through her, her daughter and future generations to come.