Lisa Romano, Acting Senior Science Advisor
Lisa Romano will serve as the acting Senior Science Advisor for the Office of Inspections and Investigations (OII).
Prior to this detail, she served as the Deputy Director for the Medical Products Inspectorate. Lisa has served the entirety of her 24-year FDA career in ORA in a variety of roles and leadership positions. She began as a CSO gaining experience in import operations, foods inspections, and medical products recall audit checks. She helped solidify what is now known as the Division of Food Defense and Targeting before moving to ORA’s Office of Enforcement where she spent several years on the health fraud team and served as the pivotal leader of the Tri-lateral Cooperation Health Fraud Group, unifying targeted regulatory operations with counterparts in Mexico and Canada. Lisa then transitioned to key leadership roles in ORA’s Office of Regional Operations (ORO), which oversaw all import operations, inspections and investigations, federal-state relations, field laboratory operations, international operations, and emergency response activities. During her tenure in ORO, Lisa was actively engaged in a variety of significant events and turning points for ORA that have become foundational to our operations today, including the establishment of ORA’s, now OII’s, Quality Management System, establishing FDA’s Third-Party audit program, and environmental sampling operations. She has extensive experience collaborating with foreign regulatory counterparts including serving as the ORA representative on CODEX CCFICS for nearly a decade and working with regulatory counterparts in Health Canada and DG-SANTE to advance global regulatory operations.
Throughout her career, Lisa has gained additional experience serving in key detail positions including New England District Director, Deputy Director for ORA’s Office of Resource Management, and Deputy Director in CFSAN’s Office of Compliance. Lisa’s extensive and varied career has allowed her to gain expertise and key insights from a variety of levels, expanding her knowledge beyond operations into important areas including human resource, budget, GAO/OIG interactions, and Congressional interactions. Lisa’s broad ORA/OII background and experience will be a significant resource for OII, and I am excited to continue to work with her to further the mission of the agency and our shared goal of advancing public health.