Michael Higgins

Well-established and seasoned Senior Regulatory Compliance leader with practical and extensive experience in the application and implementation of Good Manufacturing Practice regulations. Recognized for expertise in advising internal and external stakeholders on GMP Compliance, a critical thinker with the highest integrity.

Broad and diverse strategic experience in a variety of Compliance-related functions at highly respected companies. Accomplished subject matter expert in a number of areas including Audits, Investigations, Supplier Quality, Inspection Mgt, Regulatory Intelligence/Policy and GCP/PV. Former US FDA Field Investigator and original member of the Mid-Atlantic Regional Drug Cadre. Conducted GMP inspections, both domestically and internationally, some of which led to Official Actions by the FDA such as Warning Letters, Mass Seizures, and Consent Decrees.