
Global Quality leader with 30+ years of experience in pharmaceutical and biologics manufacturing environments, leading Quality Assurance and Validation programs supporting clinical and commercial operations. Extensive expertise in facility, utilities, equipment, computer system, and process validation within sterile GMP environments. Proven track record of building high-performing QA organizations, leading global validation initiatives, driving inspection readiness, and ensuring compliance with FDA, EU, and ICH regulatory requirements. Experienced in partnering with Manufacturing, Engineering, Technical Development, and Supply Chain teams to deliver compliant, efficient, and scalable manufacturing capabilities. Recognized for strengthening quality systems, leading regulatory inspections, and enabling successful product launches across global pharmaceutical organizations.