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    Michael Kopcha

    Director, (Super) Office of Pharmaceutical Quality "The views and information presented here are mine."

    Michael Kopcha is a highly motivated global executive with extensive experience in the pharmaceutical, generic, consumer health, device, and government regulatory sectors. He holds a Ph.D. and M.S. in Pharmaceutical Science and a B.S. in Pharmacy from Rutgers University.

    With a robust record of achievements in areas such as product innovation, pharmaceutical quality and regulations, project management, and technology transfer, Michael is a results-driven leader known for his exceptional communication and organizational skills. He excels in driving strategy, organizational efficiency, and troubleshooting complex problems, fostering cooperative relationships at all organizational levels.

    Throughout his career, Michael has held key positions including Director at the U.S. Food and Drug Administration, Vice President roles at Novartis Consumer Health/GlaxoSmithKline Consumer Health overseeing global R&D franchise, global product development, new technology/product innovation, and pharmaceutical development. He also served as Vice President at KV Pharmaceutical and Ivax/Teva, and as Director at Ethicon and Johnson & Johnson.

    With a leadership style that balances decisiveness and mentorship, Michael is adept at developing high-achieving teams. His expertise spans product development, regulatory compliance, technology transfer, and change management, making him a valuable asset in diverse organizational settings.

    Michael Kopcha
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    Location

    Silver Spring, Maryland, United States