Advancing Life Science Research through an Exploration of Drug, Medical Device and Healthcare Quality

Jun Li is a Professor of Technology and Operations at the Ross School of Business, University of Michigan. Partnering directly with healthcare providers, her research addresses critical challenges in precision health, organ transplantation, cardiovascular surgery, drug shortages, generic drug quality, and health plan design to build more efficient, personalized, and effective care models.

Dr. Li earned her Ph.D. in Managerial Economics from the Wharton School at the University of Pennsylvania and her bachelor’s degree in Operations Research and Industrial Engineering from Tsinghua University.

Justin Dierking is the cofounder of myQMS.ai, where he helps life science companies apply AI to improve quality, compliance, efficiency, and productivity across their organizations. He has more than two decades of experience in Quality, Operations, and Engineering within the medical device industry.

Prior to cofounding myQMS.ai, Justin held a variety of operations, engineering, and quality leadership roles at Boston Scientific and Medtronic, including serving as Vice President of Quality Systems at Medtronic. He began his career as an officer in the United States Air Force, where he was responsible for nuclear weapons operations.

Justin holds a Bachelor of Science in Electrical Engineering from the United States Air Force Academy and an M.B.A. from the University of Colorado Colorado Springs. He is also a certified ISO 13485 and EU MDR lead auditor.

Captain (CAPT.) Mahesh Ramanadham is the Deputy Director for the Office of Policy for Pharmaceutical Quality, within FDA’s Center for Drug Evaluation and Research, Office of Pharmaceutical Quality (OPQ). He joined the FDA in November 2009 after graduating with his Doctor of Pharmacy degree from the University of Maryland and his M.B.A. from the University of Baltimore. Within FDA, he has served in leadership roles in the Office of Compliance and the Office of Pharmaceutical Manufacturing Assessment within OPQ. Prior to joining FDA, CAPT. Ramanadham had experience in solid oral dosage manufacturing ranging from OTC products to schedule II narcotics.  Outside of FDA, CAPT. Ramanadham continues to practice pharmacy in the community setting to maintain perspective on the clinical relevancy and impact of FDA’s efforts in pharmaceutical quality.