Accomplished, broad-based FDA quality, regulatory and compliance expert with over 30 years of experience developing and leading quality, regulatory and compliance initiatives at top FDA-regulated companies. Dual background as a chemical engineer and attorney provides ability to support complex technical, operational, regulatory and legal issues within FDA-regulated companies.
Hands-on leadership experience inside large, multi-national corporations. Experience directing international, project-based teams in matrix environments on supply-chain and compliance harmonization activities. Hands-on experience applying Operational / Process Excellence methodologies to regulated operations. Ex...