Melanie
Keller
MBA
Leadership Role
Deputy Commissioner for Operations and Chief Operating Officer - Office of Operations
Melanie Keller, MBA, serves as the Food and Drug Administration's Deputy Commissioner for Operations and Chief Operating Officer. In this role, Ms. Keller leads the management of business programs and operations, including human resources and facilities, across the global FDA enterprise of nearly 17,000 world-class scientific, technical, and professional experts dedicated to promoting and protecting the public health of all Americans.
Ms. Keller brings 30 years of distinguished operational leadership within the Department of Health and Human Services. She is a recognized transformational leader and a trusted advisor to senior leadership. Before assuming her current position, Ms. Keller served as the FDA's Deputy Associate Commissioner for Operations and Deputy Chief Operating Officer, where she was responsible for directing a $7 billion enterprise budget and an operations department of over 3,000 employees delivering shared services to FDA Centers, Offices, and Programs.
Prior to that, she was the agency’s Chief Talent Officer for eight years, where she led the transformation and implementation of an alternative hiring and pay system that provides enhanced pay flexibility and faster time-to-hire for the world-class workforce the FDA requires for its public health mission. Before that, Ms. Keller served for seven years as Executive Officer in the FDA’s Center for Drug Evaluation and Research, directing a $3 billion budget and leading operations for the center, including overseeing the management functions that support drug evaluation and research activities.
Earlier in her career, Ms. Keller spent 11 years in various leadership roles at the National Institutes of Health (NIH), including as the as the Executive Officer at the Center for Scientific Review, ensuring that NIH grant applications received fair, independent, expert, and timely reviews free from inappropriate influences among other roles.
Ms. Keller holds a B.S. in Management Studies and Human Resources and an M.B.A. from the University of Maryland Global Campus and is a graduate of the Program on Negotiation at Harvard Law School.