Senior Director, IT, Gilead Sciences Inc.
Ken Shitamoto leads the IT Quality Engineering function at Gilead Sciences, which performs software quality assurance (testing), validation, and infrastructure qualification. He is a member of the FDA-Industry CSA team, and a co-author of the appendix bridging GAMP and CSA in the upcoming GAMP good practice guide on Data Integrity by Design. Ken is a multi-disciplined professional with extensive experience in quality engineering, quality management, project management, audits, and software development. He has been in the biopharmaceutical space since 1993 and has worked on the manufacturer (GXP), vendor (GCP), and consulting sides of the business. He holds a BA Molecular Cell Biology and MS Computer Science and from UC Berkeley and San Jose State University respectively. He is an avid supporter of the American Lung Association and WeHope.org (homeless services)