Bart Willnerd

Bart Willnerd is a Quality Assurance and Regulatory Compliance Leader specializing in gene therapy and biologics. With over 20 years of experience, they provide consulting services to life science companies across North America and Europe, focusing on regulatory compliance, quality assurance oversight, and process validation. Previously, Bart served as a Director of QA Technical Operations at Spark Therapeutics and currently holds a similar position at Genentech. They began their career with a B.S. in Biochemistry from the University of Nebraska-Lincoln and have worked with various pharmaceutical companies, including Wyeth and Pfizer, on projects related to vaccine production and validation.