Michelle Davis

I have extensive experience in vendor management and quality assurance within post-trial access programs, particularly in drug supply distribution and management. In my current role as Associate Director for Post-Trial Access at ICON, I oversee global vendor selection, qualification, and ongoing performance monitoring for critical supply chain partners. I lead audits, negotiate and implement quality agreements, and ensure adherence to GxP standards. My work involves establishing and refining SOPs, developing compliance frameworks, and managing relationships with manufacturers, logistics providers, and patient service vendors to maintain regulatory compliance and ensure uninterrupted access to investigational products for eligible patients.

Results-oriented Quality and Clinical Operations leader with 18+ years in the pharmaceutical, biotech, and CRO sectors, bringing a strong blend of vendor management, quality assurance, and post-trial supply expertise. Skilled in vendor selection, audits, and quality agreement negotiations, with proven success in building and optimizing QA frameworks for lean organizations. Adept at working in early-phase development environments, particularly Phase I clinical programs, to ensure compliance, operational efficiency, and readiness for commercialization. Known for cross-functional leadership, regulatory compliance expertise, and patient-centered drug supply solutions.