Kelly Simpliciano

Kelly Simpliciano is the Director Audit Management, Global Quality Assurance GCP at BioNTech SE. Prior to joining BioNTech, Kelly held various roles at Bristol-Myers Squibb, including Associate Director in Global Quality - Clinical Trials & Safety, Associate Director in Information Technology Quality Assurance (ITQA), and Associate Director in R&D Quality, Information Technology Quality Assurance (ITQA). Kelly's expertise lies in auditing Investigator sites, clinical vendors, and internal audits within the Global Quality organization. With a background in environmental science from Rutgers University and a Master of Science in Quality Assurance and Regulatory Affairs from Temple University, Kelly has demonstrated strong leadership in computer system validation efforts and IT compliance audits.