Senior Director, Global R&D Audits & Inspections Readiness

Role: Senior Director, Global R&D Audits & Inspections Readiness, leading compliance and inspection preparedness for biopharmaceutical R&D systems. Responsibilities: embed GxP validation-by-design into Agile workflows and CI/CD pipelines; orchestrate internal, mock, and health authority inspections; ensure externally sourced R&D IT systems maintain continuous compliance; interpret global regulations (FDA 21 CFR Part 11, EMA Annex 11); manage risk, CAPAs, and compliance metrics; lead and develop a cross-functional team. Requirements: Bachelor’s in Computer Science, IT, Bioengineering, or related; 12+ years in IT compliance, quality assurance, or software engineering within pharma/biotech; 5+ years leading audit/inspection activities, with experience integrating GxP into Agile/Scrum environments and automated pipelines. HighValue: deep regulatory expertise (FDA, EMA), computerized systems validation (CSV) and modern CSA methodologies, data integrity (ALCOA+), and healthcare privacy (HIPAA, GDPR); experience with health authority audits and vendor assessments. WorkSetup: some travel expected.