Jennifer McCafferty, Ph.D.
Senior vice president, head of CMC-regulatory and MRL quality assurance
"I’m proud of the work we’re doing that connects science, product and patient through securing regulatory approvals with our global health authorities. We’re focused on continuing to evolve our capabilities to progress our exciting new pipeline submissions, while ensuring the quality and compliance of our existing product portfolio."Years at Merck Research Laboratories
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Jennifer McCafferty is senior vice president, head of CMC-regulatory and quality assurance at Merck Research Laboratories (MRL). In this role, Jennifer leads the global regulatory affairs CMC organization, while also assuming cross-divisional (R&D and manufacturing) responsibilities for medical device combination products, quality management for new pipeline modalities and change control. McCafferty also leads the quality assurance organization which serves as an independent organization providing quality oversight to ensure subject safety and research integrity throughout the drug development lifecycle within MRL.
Prior to this role, McCafferty was vice president, large molecule external manufacturing operations, leading the company’s global external contract manufacturing (CMO) network to supply the growing vaccines and biologics portfolio of new pipeline and commercial products. McCafferty’s more than 25-year career includes leadership positions across analytical sciences, factory and CMO operations, quality systems, quality control, CMC regulatory, commercialization and business development, as well as enterprise change program assignments across the pharmaceutical, consumer health, vaccines and biologicals business units of Merck and GlaxoSmithKline.
McCafferty serves on the government affairs committee for the board of visitors and sits on the chemistry department executive advisory board at UNC-Chapel Hill, where she earned her Ph.D. in analytics chemistry. She also holds a bachelor’s in chemistry from Colgate University. Known as a collaborative and dynamic leader with a passion for mentoring, she was recognized as one of Healthcare Businesswomen’s Association 2023 Luminaries.
