Ray Gaines is the Branch Chief of Global Compliance Branch 3 in CDER’s Office of Compliance, Office of Manufacturing Quality, Division of Drug Quality I. He has a background in chemistry and over 27 years’ experience between industry and FDA. He started his career as a chemist in a global pharmaceutical company in an R&D lab and moved to plant quality compliance and later managed global contract manufacturers. He was involved with due diligence audits, new business development, and quality and compliance activities. Ray joined FDA in 2011 as an Interdisciplinary Scientist and has also served as a Team Leader. As Branch Chief he oversees the review of violative (OAI) facility inspection reports. Ray holds BS degrees in Chemistry and Biology from Virginia Commonwealth University.