Director, Quality, CCRM
Steven Keizer, Director, Quality at CCRM has been designing, building and operating quality systems to fit the pharma industry for the better part of a decade, spanning mostly larger commercial level applications, but is now more focused on the smaller, early phase applications. Starting his career at Wyeth Manufacturing as a QC manager, involved in the transfer of a product line from a US site to a Canadian manufacturing site. After Wyeth was sold to Pfizer and the transfer project was completed, he moved on to helping DSM secure an API customer base for their nutritional products through effective implementation of risk based quality systems. His latest challenge is with the newest field to hit the healthcare market, which is regenerative medicine. Through the effective delivery of a quality management system to meet the needs of the customer, whether that be internal (in-house supply chain) or external (Contract Manufacturing Organization), the same principles apply. Use of quality risk management is most appropriate applying the same principles to early phase projects, and another element of risk needs to be addressed, and that is, the risk to the industry if innovation is stifled. Steven holds an B.Sc Hons. in Analytical Chemistry from the University of Western Ontario and an MBA from the Sauder School of Business at the University of British Columbia, with focus on Strategy and OBHR.