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Online

The Current State of Quality Oversight (QO) in the Pharmaceutical Industry

Speakers

John R. Wilson, PhD

John R. Wilson, PhD

Senior Vice President, Beaufort LLC, United States

John Wilson is currently Senior Vice President of Beaufort LLC, a boutique CRO. John has broad-based experience in clinical research and pharmaceutical manufacturing, regulatory strategy and compliance, and quality management. John holds a Ph.D. in medical ethics.

Coleen  Glessner, MBA

Coleen Glessner, MBA

Senior Vice President, Chief Quality Officer, Alexion Pharmaceuticals, United States

As Vice President, Head of Research and Development Quality and Compliance at Alexion, Coleen leads the establishment of a quality management system for R&D to assure the highest standards of Quality in ultra-rare diseases. Most recently, she has been focused on implementing sustainable processes and controls for Alexion’s accelerated growth while developing a culture of quality. She has a BS from the University of Pittsburgh and an MBA from MIT.

Sarah Jane  Constantine

Sarah Jane Constantine

, United States

Sarah Jane Constantine is an Associate Director of Clinical Operations at Takeda Oncology. Over the past 16 years, Sarah Jane has held various positions within clinical quality and compliance for both CRO and Sponsor companies. She began her career at PAREXEL as a Clinical Research Associate. In addition, she was Manager of Site Selection Services at PAREXEL, Clinical Trial Manager at Wyeth, Clinical Project Manager at Cynosure, Senior Manager of Clinical Quality and Compliance at Biogen Idec, Associate Director of Clinical Operations at Biogen Idec, Hemophilia and Senior Manager of Clinical Trial Oversight and Compliance at Cubist.

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