Greater Rouen Metropolitan Area
C‑suite Pharmaceutical Quality & Regulatory Executive with 35+ years of global leadership across pharma, biotech, vaccines, API, CMOs, and cold‑chain logistics. Recognized for delivering inspection‑ready organizations under pressure, with a record of 12+ successful FDA inspections (PAI and routine) across Europe and global networks. Specialist in sterility assurance, data integrity, lifecycle validation, and crisis remediation, trusted by top‑10 pharma and high‑growth biotech organizations when regulatory failure is not an option. Calm, decisive leader who transforms fragmented quality systems into high‑execution, regulator‑credible operations—aligning compliance, operational excellence, and business continuity at scale.
Including GxP consulting for Biotech, Pharma, lifescience Logistics & Digital IT
Building an entrepreneurial consultancy serving the Pharmaceutical, Biotech and Life-science Logistics industries
Driving forward the IPEL project across Air, Ocean, Road, Rail & Courier Freight to enable reduction in level 3 CO2 emissions. Promoting infrastructure changes that can enable such reductions eg. Global investment in Ocean & Rail hubs.
Monitor complex set of inputs including current environment, industry trends and emerging regulations in order to anticipate potential risks and the need for changes and influence site and global management directions regarding new or revised strategic initiatives. Analyze results of quality system assessments conducted within the network and align strategic improvements with site and global stakeholders.
Management of Quality, Regulatory and EHS policy at all NextPharma sites. Maintaining FDA compliance and improving quality throughout the company.