Grace McNally

Senior Vice President
Greenleaf Health, Inc.
 

 

Grace McNally joined Greenleaf Health after a 33-year career with the FDA.  At Greenleaf, she provides strategic guidance and support to pharmaceutical and medical technology companies in areas including strengthening corporate quality systems, developing compliance strategies, ensuring inspection readiness, and assisting industry clients in developing and communicating corrective actions plans.

Grace began her FDA career as an ORA investigator conducting drug and medical device inspections before moving to CDER as a Compliance Officer. Later, as a Senior Policy Advisor in the Office of Compliance she developed CGMP guidance and revisions to the CGMP regulations and supported implementation of CDER quality initiatives, ICH quality guideline and new legislation impacting  In 2015, Grace moved to the Office of Process and Facilities within the newly formed Office of Pharmaceutical Quality (OPQ) and served as an acting Branch Chief. She finished her FDA career in OPQ’s policy office as the Director, Division of Regulations, Guidance and Standards, where she oversaw the development of quality (CGMP and CMC) guidance for drugs requiring premarket approval as well as OTC monograph medicines. 

Grace holds a B.S. in Physics from Boston College, Chestnut Hill, MA.

 

Sessions: 

Communicating with the FDA: How to Facilitate an Inspection Post-COVID