Senior VP for Quality and Regulatory Affairs, Sysmex Americas, Lincolnshire, IL
Dr. Eric Kolodziej is currently SVP, Quality, Regulatory and Clinical Affairs for Sysmex Americas. He is responsible for all medical and clinical affairs, regulatory submission activity, and quality operations and systems.
Dr. Kolodziej was formerly the Global Head of Quality and Regulatory Affairs for Roche Diagnostics. In this role, he was responsible for all Manufacturing/Supply Chain quality operations, global regulatory submissions and registrations, regulatory compliance, and complaint handling and reporting. He was the principle interface to all regulatory agencies globally for Roche Diagnostics, and for all regulatory issues related to Roche’s Companion Diagnostic and Digital Health initiatives.
Before joining Roche, Dr. Kolodziej was Global Vice President of Quality and Compliance for Perrigo Consumer Healthcare, the world’s largest manufacturer of over-the-counter generic pharmaceuticals.
Dr. Kolodziej has also held several senior management positions in R&D, Quality, Manufacturing, Technical Service, and Finance in both the pharmaceutical and chemical (API and excipient) manufacturing industries, and has had held assignments in various sites in the US, UK and in France.
Dr. Kolodziej is the author of over 40 publications and presentations in the areas of drug and device development, regulatory compliance and strategy, analytical chemistry, drug metabolism, lab and quality management, and technology valuation. In addition, he has served on several industry advocacy groups and participated in several FDA/industry panels.
Dr. Kolodziej received his Bachelor of Science in Chemistry from Valparaiso University in 1982 and completed his Ph.D. in Analytical Medicinal Chemistry in 1986 from Purdue University. Dr. Kolodziej also holds an Master in Business Administration in Finance.