Director, Vendor Management & Inspection Readiness

10+ years of vendor management and inspection readiness experience in regulated industries Bachelor’s or Master’s degree in Life Sciences, Bioinformatics, Computer Science, or related field Proven experience implementing/managing vendor relationships and driving performance improvements Proven experience implementing/managing inspection readiness programs and driving remediation efforts Strong communication and interpersonal skills Solid understanding of GAMP5 risk based computerized systems validation methodology Solid understanding of regulatory requirements (GxP, GLP, GCP, CLIA, data integrity)

Manage vendor relationships and performance Ensure vendor compliance with regulatory requirements Develop and maintain inspection readiness programs Conduct internal audits and gap assessments Lead remediation activities and track CAPAs Ensure effective document control and quality systems Stay updated on regulatory expectations and best practices