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.