Kopcha Selected to Head FDA’s Quality Office

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PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-10-07-2015, Volume 11, Issue 10

Michael Kopcha has been named to lead CDER’s new Office of Pharmaceutical Quality.

Michael Kopcha, a pharma industry veteran with 25 years of experience in formulation and process development, process validation, technology transfer, off-shoring/outsourcing, and change management, has been named the permanent director of FDA’s Office of Pharmaceutical Quality (OPQ), according to a Sept. 25, 2015 announcement by Janet Woodcock, director, Center for Drug Evaluation and Research (CDER). Kopcha will join CDER in November pending ethics clearance.

FDA’s OPQ was launched in January 2015 to implement processes and policies to provide better alignment among review, inspection, and research functions.

Kopcha will lead OPQ in planning and implementing strategies to drive pharmaceutical quality, with a goal of providing for an efficient pharmaceutical manufacturing sector that reliably produces high-quality medicines without extensive regulatory oversight, Woodcock reported in the announcement.

Kopcha recently served as vice president, and global research and development franchise head, for cough, cold, and respiratory products at Novartis Consumer Health in New Jersey. He joined Novartis in 2008 as the global head for pharmaceutical and analytical development, later serving as global head for new technologies and product innovation, and vice president and global head for global product development.


Previously, he was vice president for pharmaceutical development at KV Pharmaceutical, Inc. in St. Louis, where he directed and managed analytical research and development, product development, process development and technology transfer, stability, drug delivery, project management, and external alliance. His experience includes related roles with Schering-Plough, J&J, and Ivax.

Kopcha holds doctorate and Master’s degrees in pharmaceutical science, and a bachelor’s degree in pharmacy, from Rutgers University in New Jersey. He served as an adjunct assistant professor in the Department of Pharmaceutics, Ernest Mario School of Pharmacy at Rutgers.   

Source: FDA trade press announcement