Cheryl Basile has Fifteen years’ experience in Quality Assurance and Regulatory Affairs for biologics including drug/medical device combination products. She has developed, implemented, and managed global programs for mock pre-approval inspections, employee training/qualification, and audits of vendors, internal GMP operations, and electronic systems. She holds a Bachelor of Science in Biomedical Engineering and a Master of Public Health. Cheryl is currently Manager, QA-GMP Planning & Management at Daiichi Sankyo, Inc. where she is responsible for the organization’s vendor audit and qualification program; she is also the computer system owner for the clinical batch release and vendor audit operations.
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