Grace E. McNally FDA

Ms. McNally is the Director, Division of Regulations, Guidance and Standards, in CDER’s Office of Policy for Pharmaceutical Quality (OPPQ). OPPQ is responsible for developing and communicating science- and risk-based policies & standards related to drug product quality, including application assessment & inspection. She oversees the development of regulations and guidance governing the drug quality lifecycle as well as a team managing CDER’s interactions with USP and standards development organizations.

Grace previously served as an acting Branch Chief in OPQ’s Office of Process and Facilities (OPF). Prior to OPQ Grace held various positions within CDER’s Office of Compliance, including Compliance Officer, Sr. Policy Advisory and acting Branch Chief for policy within Compliance. During her time in Compliance she developed CGMP cases, and led or participated in policy and regulation workgroups in the areas of process validation, combination products, CGMP/quality systems, and manufacturing science.

Grace began her FDA career as a field investigator in Philadelphia District and later joined Denver District specializing in pharmaceutical and medical device inspections. She graduated with a B.S. in Physics from Boston College, Chestnut Hill, MA.