Calvin Kim

Director Digital GxP Compliance Management, Bayer

Calvin is a seasoned quality professional with over 25 years of experience in various sectors of GXP regulated industries. As a core member of Bayer QA organization responsible for quality oversight and regulatory compliance assessment of computerized systems (CS) and technology used in pharmaceutical, consumer health, animal health, and medical device sectors across a global company, he has completed more than 200 audits of IT suppliers and CS projects. Considered as a thought leader in CS validation practices, and electronic records and electronic signature related regulations within the organization, he is passionate about engaging in CS implementation and data integrity compliance discussions with the industry colleagues around the world. He is actively engaged in various industry forums, including his current role as Chair for DIA’s Information Quality, Compliance, and Technology (DIA IQCT) Community and Co-chair for Mid-Atlantic Regional Society of Quality Assurance (MARSQA) Computer Validation Committee (CVC).