Dr. Lynne Ensor is a Senior Vice President and the Head of Global Strategic Compliance Consulting at Parexel International. She has been a consultant to the biopharmaceutical industry since 2019, with expertise in sterile product manufacturing, regulatory strategy, and manufacturing facility remediation to ensure regulatory compliance and patient access to quality medical products. Lynne is currently a member of the U.S. Pharmacopeia Microbiology Expert Committee (USP 2020-2025 Council of Experts). She was previously employed by the FDA for 21 years, including having served as the Deputy Office Director in the Office of Process and Facilities/OPQ/CDER. Her prior experience includes Roche Biomedical Laboratories, the Discovery Channel, and the University of Maryland’s School of Medicine.