Nikunj Patel

Nikunj Patel is a highly experienced professional in the field of Digital Systems Compliance and Quality Assurance, currently serving as the Director of Digital Systems Compliance at BioNTech SE since January 2023. With a solid background in clinical development and regulatory compliance, Nikunj has previously held key roles at EMD Serono, Inc. as Associate Director and Sr. Manager in QA, where responsibilities included audit readiness, vendor oversight, and development of R&D policies related to electronic systems. Other significant positions include experience at Gilead Sciences and Biogen, focusing on quality oversight, validation processes, and compliance with regulations such as 21 CFR Part 11. Nikunj holds an MS in Pharmaceutical Engineering from the New Jersey Institute of Technology and a B.Pharm. from Gujarat University.