Lisa Romano, Acting Deputy Associate Commissioner for Medical Products (DAC-MP)
Lisa Romano will serve as the acting Deputy Associate Commissioner for Medical Products (DAC-MP) for the Office of Inspections and Investigations (OII).
Lisa is a seasoned professional in regulatory operations, public health, and medical product safety, having served as the Deputy for Technology and Bioresearch Quality and Support Operations (DTBQSO) in the OII Office of Medical Products Inspectorate (MPI). Ms. Romano has served in this position for two years, overseeing and coordinating field operations related to recalls, consumer complaints, and quality system activities relative to bioresearch monitoring and medical devices.
Ms. Romano brings a wealth of experience in providing strategic guidance and leadership to OII field operations, she has an ORA/OII field operations background and has served in similar leadership positions for years. Ms. Romano has overseen significant programs akin to the medical products program for several years including her tenure as the Deputy Director of the Office of Regional Operations, which was responsible for providing guidance, direction, and oversight of all ORA field operations in all FDA regulated program areas including drugs, devices, biologics, and human and animal foods. This role also included import operations, laboratory operations, state-federal relations, domestic and foreign operations. Lisa also served as Deputy Director OFFO and Deputy Director OHAFO with responsibility for oversight of day-to-day field operations, emergency response activities, recall and consumer complaint activities, state liaison activities.
In all these roles, Lisa served as the technical expert with additional responsibility for management of the operation and office budgets and the human resources. She has successfully built from scratch new operation programs for the agency, ensuring internal and external stakeholder needs are addressed, building new IT platforms to oversee program operations and allow for electronic communications between regulated industry and the agency.
Ms. Romano brings a wealth of expertise from opportunities within FDA and her career prior to joining the agency. Prior to joining the FDA, she supervised a microbiology laboratory for a significant drug manufacturer for several years. Her experience there included supervisory responsibilities including human and financial resource oversight and obligation, equipment purchases and validation, media responsibilities and a breadth of microbiological testing of all ingredients used in the manufacture of drug products, including the testing of water used within the facility. She spent time on the production floor, in sterile environments and in research and development.
Lisa’s breadth of experience has led to her being known as a pivotal and strategic resource for OII and her engagement and dedication to the mission of public health has led to a stronger and better positioned agency.