Associate Director, IT CSV and Compliance

Job description

Job Description We are seeking an experienced IT Compliance leader to establish and oversee a robust, risk-based validation program supporting our regulated systems and data across the enterprise. This role ensures computerized systems remain compliant, inspection-ready, and aligned with global regulations including GxP, GDPR, HIPAA, and other privacy requirements. The Associate Director will lead our Computerized System Validation (CSV) / Computer Software Assurance (CSA) framework, serving as the primary IT compliance lead for FDA, EU, partner, and internal audits and inspections. This individual will partner closely with Quality, IT, Security, Privacy, and business stakeholders to ensure validation lifecycle governance across system implementations, changes, integrations, and retirements. Key Responsibilities: - Lead and continuously improve the enterprise CSV/CSA framework, including policies, standards, templates, and governance processes. - Define and implement risk-based validation strategies aligned with regulatory expectations and CSA principles. - Serve as IT lead during regulatory inspections and audits, ensuring inspection readiness and managing responses, CAPAs, and fo...