Cylia Chen-Ooi, MS Amgen Inc.

Co-leader of PDA Quality Metrics/Culture Task Force Team
Director of Quality, External Affairs (North America), Amgen Inc.

Cylia currently co-leads a panel of experts from industry to develop PDA’s quality culture assessment tool to help industry advance understanding and maturity of quality culture at their companies. Working with various companies in her PDA role Cylia has trained over 100 regulators on the PDA quality culture assessment tool. At Amgen, Cylia develops external engagement strategies and is actively engaged with several industry associations such as PhRMA, BIO, PDA, RX-360, ISPE, and others. Prior to her current role, she led several initiatives for Amgen’s international expansion in the Asia region and she has extensive experience in fill-finish process development. She holds a Master’s degree in Regulatory Science and a B.S. degree in Biomedical Engineering from the University of Southern California.