AFDO RAPS Healthcare Products Collaborative
Breen Grace




MGB Solutions

Grace Breen is a consultant with over 30 years of experience in the pharmaceutical industry. She is the former Head of Quality for SCA Pharma and had held global leadership roles at Impax, Hospira, and Catalent. Grace has Quality and Compliance expertise spanning API’s, solid oral and parenteral dosage forms, and infusion devices. At SCA Pharma, a 503B outsourcing company, Grace led a cGMP cultural transformation; at Impax, she implemented a contemporary and integrated Quality and Compliance strategy; and at Hospira, she led a global Commercial Quality team that focused on the needs and satisfaction of the customer. Grace earned a post-graduate diploma in Pharmaceutical Manufacturing Technology from Trinity College Dublin, Ireland; an M.S in Chemistry from Dublin City University, Ireland; and a B.S. in Chemistry from University College Cork, Ireland. She is eligible to act as Qualified Person (QP) under EU law.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.


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