2024 PDA/FDA Joint Regulatory Conference

Mary E. Farbman, PhD Merck & Co., Inc.

Mary E. Farbman, PhD

Mary E. Farbman, PhD Merck & Co., Inc. Associate Vice President, Global Quality Compliance

Mary Farbman leads the Global Quality Compliance Support organization at Merck and Co., Inc.. Her areas of responsibility include the global CGMP auditing team, a compliance and remediation team, a microbiological and sterility assurance controls organization, and the divisional team responsible for digital data quality. She previously worked at FDA/CDER’s Office of Compliance, where she was responsible for authoring and reviewing warning letters and other compliance documents, conducting microbiological reviews of therapeutic protein manufacturing processes, and performing pre-license inspections of BLA products. In industry, she has worked at both the site and global levels in various compliance and auditing roles as well as in the R&D arena. Her areas of expertise and interest include biotechnology, sterile products, and analytical techniques. Before joining the industry, she served as a Peace Corps volunteer in West Africa, teaching high school chemistry, physics, and mathematics. Mary holds a doctorate degree in biological chemistry from MIT.