Senior Consultant Kelly Waldron Earns PhD

Senior Consultant Kelly Waldron has earned a PhD in Pharmaceutical Regulatory Science, with a specialization in Quality Risk Management (“QRM”), from the Dublin Institute of Technology, Ireland. Research for Waldron’s thesis, “Managing Risk to the Patient: Recoding Quality Risk Management for the Pharmaceutical and Biopharmaceutical Industries” spanned three years and included insight from multiple industry regulators, QRM practitioners, and the Parenteral Drug Association (“PDA”).

Kelly’s research focused on defining how a QRM program should be designed and deployed to deliver value in an effective and efficient way. She developed a QRM maturity model to measure a site or company’s progress toward this ideal state.  “Using this QRM maturity model, ValSource’s QRM Solutions Group now benchmarks our clients’ QRM programs and implementation with their industry peers, competitors, and regulator expectations,” Waldron explained. “By developing improvement plans and tailoring solutions specifically to individual businesses’ needs and culture, we accelerate the return on investment of QRM programs.”

Kelly WaldronKelly’s experience and 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, audit and inspection programs and response, stability programs, and design control. In addition, Kelly has particular expertise and a specialized focus on the development and implementation of innovative approaches to QRM.

Prior to joining ValSource in 2017, Kelly managed Global Quality Risk Management and Design Control at Sanofi. Kelly has authored numerous industry and academic papers on QRM and conducted much of her academic research in collaboration with the PDA. Prior to achieving her PhD, Kelly received a BA in Biology from Boston University and an MBA in Pharmaceutical Management from Fairleigh Dickinson University. She can be reached at