Senior Vice President, Global Quality, Technical Operations
Charlene is accountable for the global Quality function at Shire, a global biotechnology company focused on meeting unmet medical needs of patients with rare diseases and specialty conditions. In partnership with her colleagues at Shire, Charlene and her team provide a safe and ready supply of quality products and services to our patients and healthcare providers.
Charlene has more than 25 years in the biopharmaceutical industry bringing new products and technologies to fruition through robust team partnerships. Prior to joining Shire, she held leadership positions at Gilead Sciences, Cell Genesys and Chiron Corporation. She holds a Bachelor of Science degree in biochemistry from the University of California, Davis and a Masters in international business from Saint Mary’s College in Moraga, California.
Alonza Cruse (invited)
Director, Office of Pharmaceutical Quality Operations, Office of Regulatory Affairs
Art O. Czabaniuk (invited)
Program Division Director, Division of Pharmaceutical Quality Operations III, ORA
Mr. Czabaniuk holds a B.S. degree in in environmental health and has 40 years of experience in public and private scientific organizations. Mr. Czabaniuk is currently serving as the FDA/ORA Program Division Director (PDD) for the Division of Pharmaceutical Quality Operations III. He is one of four national PDD’s responsible for pharmaceutical regulatory oversight in 13 Midwest states including, MI, IN, OH, KY, IL, MO, KS, NE, IA, MN, WI, SD, and ND.
Prior to joining the FDA in 2002, Mr. Czabaniuk was an independent consultant in the contract pharmaceutical testing industry. His primary responsibilities were laboratory management and the review of Pharmaceutical analytical data including finished product release and validations related to NDA/ANDA applications. Mr. Czabaniuk began his career in the environmental testing industry (18 years) where he held numerous scientific and managerial positions. Management positions included: Branch Manager, Laboratory Director, VP General Manager for a Division of three multi state environmental testing laboratories, and corporate QA Director for national network of 8 environmental/radiochemical laboratories. He also served as a Project Manager for: nuclear/chemical hazardous waste clean-up investigations; industrial wastewater/groundwater/surface water contamination studies; and source and ambient air pollution studies.
Vice President, Quality and Regulatory Affairs
IBM Watson Health
John joined IBM in May of 2016 and is responsible for ensuring Watson Health’s portfolio complies with all relevant lifescience related regulations. Prior to joining Watson Health, John was with Boston Scientific for nine years and had a number of positions there including the head of International Quality, Distribution and Supply Chain and management board level positions for their Endoscopy and Urology and Women’s Health. Prior to Boston Scientific, John worked for Johnson & Johnson and held quality related positions in their device, diagnostic, and pharmaceutical sectors. John has over 20 years of experience with FDA regulated industries and has special expertise in Design Control, Software Quality, and Quality Systems.