Kelly Waldron, PhD ValSource Inc.

Dr. Kelly Waldron is currently the Business Unit Manager (Quality and Manufacturing Science) and a Senior Consultant with ValSource, as well as a member of the Pharmaceutical Regulatory Science Team (PRST) at the Technological University Dublin (formerly Dublin Institute of Technology) in Dublin, Ireland. She has particular expertise and a specialized focus on the development and implementation of innovative approaches to quality risk management (QRM) and has authored numerous industry and academic papers on the topic. Dr. Waldron’s expertise extends to various quality functions in the pharmaceutical, biopharmaceutical, and medical device industries, including quality system design, quality strategy and planning, deviations/investigations, CAPA, change management, data integrity, audit and inspection programs and response, and design control. She holds a BA in biology from Boston University, an MBA in pharmaceutical management from Fairleigh Dickinson University, and a PhD in pharmaceutical regulatory science (thesis in QRM) from the Dublin Institute of Technology. She currently resides in New Jersey, USA and can be reached at kwaldron@valsource.com.