Global Head Compliance and Inspection Management
Michael Higgins has well over 25 years of experience in the Pharmaceutical and Health related industries. He began his career with the US FDA, in the midst of the Generic Drug Scandal and accelerating globalization of the Supply Chain. At the FDA, Michael conducted numerous GMP inspections globally, and at the time, was a member of Mid-Atlantic Pre-Approval Drug Cadre based in New Jersey. After five years with the FDA, Michael held a number of leadership positions at Novartis and subsequently Johnson and Johnson. Predominantly, his career focus has been Compliance, working on numerous remediation projects, both large and small in his former companies. At Novartis, Michael led the first Corporate Wide Data Integrity Initiative as well as several site remediation projects. Michael joined Johnson and Johnson as the Vice President of Corporate Policy and Remediation shortly after the Consent Decree was signed with the FDA. He managed the Corporate verification efforts related to the Consent Decree and was instrumental in building programs to ensure sustained compliance across the Johnson and Johnson Network.
Michael holds a Bachelor of Science in Chemistry from Binghamton University, NY, and an MBA with Honors from Iona College, NY.
As a Senior Compliance Policy Advisor for Roche-Genentech, Michael currently works on key Compliance initiatives both internally and externally for the company. He is based in Washington DC.