• Successful track record of over 23 years in global manufacturing, engineering, supply chain, CMC development, and program management.• Extensive experience developing, scaling up and commercializing drugs, biologics, medical devices, and combination products.• Expert people and project manager with extensive experience managing cross-functional teams spanning multiple countries and organizations.• Successfully managed various functional areas in pilot and commercial production facilities, both in house and CMO.• Led organizations through quality compliance upgrades and participated in numerous successful pre-approval inspections (FDA and EMA).• Thorough knowledge of 21CFR 210/211, 21 CFR 820, ISO 13485 as well as TS16949 and ISO 9001 quality standards• Expert in design controls for medical devices and combination products.• Led execution of capital projects in excess of $150MM.• Expert in supply base development, management, contracts administration and negotiations.• Deep experience and understanding of API, sterile dosage form, non-sterile dosage form, medical device and combined products design, development, and manufacturing.• Strong background in business analysis, risk management, strategy development, change management, organizational design, development, and transformation.