Richard O’Keeffe is Director of International Quality at Amgen Inc in Thousand Oaks, California, with responsibility for GMP/GDP-related activities in the Asia region. Richard led Amgen’s implementation of ICH Q9 and has worked with Amgen since 2006, also working in QA & Compliance leadership roles with Amgen in Ireland and the Netherlands. He worked with Schering-Plough for 16 years in Quality roles in Ireland, Singapore and New Jersey. His experience is primarily in the aseptic filling and supplier quality management fields, but he has managed all QA, QC and site Regulatory functions. In Singapore, Richard led the Quality team through the design, qualification and EMA/FDA approval of Singapore’s first biologics aseptic filling facility.