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Lesa Valentine

Lesa Valentine

Global Head, Essential Medicines Quality Unit

Ms. Valentine works to establish, implement, and advance global quality systems for all drug and vaccine development at PATH. Whether PATH’s role is to develop, evaluate, and/or introduce a product, she and her team help ensure that it will meet or exceed quality and safety standards. For all nonclinical and clinical evaluations, her team oversees strict adherence to relevant regulations and industry practice. Ms. Valentine’s focus is on fostering an environment that supports continuous improvement and fact-based decision-making that complies with every aspect of drug development regulations.

Under her leadership, PATH combines quality principles, compliance with regulatory expectations, and risk management. This approach applies both internally and in collaboration with our partners, such as manufacturers, research organizations, and laboratories. The Quality Unit operates as an independent team to enable impartial assessments.

Ms. Valentine brings to PATH three decades of diverse experience in all aspects of regulated pharmaceutical products. Previously she worked with Amgen, Genentech, and Roche in both biologics and small-molecule drugs, as well as in the Novartis vaccines division. Her background includes auditing and inspection management; quality systems implementation and improvement; facility design and start-up; nonclinical study execution; clinical trial compliance; bioanalytical and manufacturing laboratory control; and oversight of vendors and consultants.

Ms. Valentine is based in San Francisco. She holds a bachelor’s degree from the University of Wyoming.