Alicia Mozzachio

Alicia Mozzachio is currently the Senior Advisor for International Activities in the Office of Policy for Pharmaceutical Quality (OPPQ) within the newly formed Office of Pharmaceutical Quality (OPQ) in FDA’s Center for Drug Evaluation and Research (CDER). Alicia serves as a technical lead on GMP-related policy projects focusing on those policies with a global impact. She represents the interests of CDER/OPQ while working with international organizations and collaborates with the FDA foreign offices to positively impact the quality of medicines.

Prior experience includes serving as the Branch Chief for the International Compliance Branch 1 within the Division of International Drug Quality (DIDQ), Office of Manufacturing and Product Quality (OMPQ), Office of Compliance (OC). Alicia’s branch was responsible for evaluating FDA’s international drug inspection reports and determining the actions to be taken against firms failing to comply with CGMP.

Alicia has been with the FDA for 22 years in various job roles (investigator and compliance officer) and locations. Her educational background includes bachelor’s degree in pharmacy and a master’s degree in public health. In addition to her FDA roles and responsibilities, Alicia has deployed with the Public Health Service (PHS) to provide aid to victims impacted by disasters.

Alicia has been a member of the FDA Course Advisory Group for FDA’s Basic Drug School since 2009, teaching new investigators the basics of conducting drug inspections. She is recognized as a subject matter expert in the areas of cleaning validation, topical drug products, clinical significance and APIs. She has also given numerous presentations at national and international conferences.