Warren Kenzie

Built and established a risk based quality management system, focusing effort on work that protects patients and delivers quality products. Joined a company as the third quality employee at the start of phase 3 clinical trial and grew the site Quality team to prepare for commercial launch. 21 years of commercial and clinical manufacturing experience in various roles. Managed and hired strong technical teams during plant startup, equipment qualification, and product transfers. Developed the site risk program and drove a relentless focus to identify / correct defects early in the engineering phase of projects. Built a team and processes that enabled a product transfer in 123 days from another company (typical transfer time is 12 months). I have extensive knowledge of pharmaceutical Quality systems (CAPA, change management, and defect evaluation / resolution). I have extensive experience as a root-cause analysis lead. Finally, I also have a strong technical background including: manufacture of mammalian cell culture / chromatography processes, risk assessment development and execution, and qualification / validation of equipment, computer systems, and processes.