Amber Gaddy

Associate Director of Regulatory Assurance

In two decades at MURR, Amber Gaddy has facilitated MURR’s transformation from a more research-focused center to a quality system driven organization. Development is her bread and butter; she developed many of the foundations for MURR’s current quality system, including MURR’s first document and records management programs and MURR’s first GMP procedures and policies.

In addition, she has a deep background in regulatory affairs in diverse areas including nuclear licensing and radioactive materials transport. She authored and led implementation of the current MURR Type B Shipping Quality Assurance program, approved as a license by NRC.  Gaddy was also a core member of the implementation teams for all three of MURR’s currently-marketed GMP products.

Today her role continues to be both interdisciplinary and strategic, with focus areas in FDA regulatory affairs, contracting, quality system continuous improvement, and GMP project implementation.