Quality Assurance Validation & IT, Director

Responsibilities

• Lead and manage QA staff responsible for audit execution and IT quality initiatives.
• Mentor QA team members and support development through training in best auditing practices and IT quality standards.
• Drive IT Quality strategy through continuous improvement initiatives, special projects, and process enhancements.
• Plan, conduct, and oversee IT and computerized systems audits, including internal, vendor, and for-cause to ensure compliance with GxP regulations, contractual obligations, and internal standards.
• Prepare, or review, and approve audit plans, reports, and audit responses within defined timelines.
• Support sponsor audits and regulatory authority inspections.
• Report audit and inspection outcomes and support Root Cause Analysis (RCA), Corrective and Preventive Actions (CAPAs), and effectiveness checks through closure.
• Monitor SaaS providers compliance using risk‑based approaches and performance signals.
• Partner cross‑functionally (Vendor Management, IT, and Business teams) to ensure alignment on quality standards.
• Support IT related vendor qualification and provide oversight of the GxP audit program.
• Contribute audit insights and trends to Quality Risk Management for continuous risk mitigation.
• Provide Quality oversight of Computer System Life Cycle (CSLC) activities, including implementation, validation, change management, maintenance, periodic review, and decommissioning.
• Review and approve validation documentation and ensure adherence to data integrity and Electronic Records/Electronic Signatures (ERES) requirements.
• Serve as QA Subject Matter Expert (SME) for CSLC frameworks and IT quality processes.
• Ensure changes to systems and infrastructure are controlled, risk‑assessed, and compliant with regulatory expectations.
• Review IT related SOPs and policies.
• Lead initiatives to strengthen data integrity, inspection readiness, and compliance processes.
• Collaborate with IT and business functions to streamline GxP system compliance processes.
• Support training programs to enhance organizational understanding of IT quality and compliance requirements.
• Review and approve investigations, deviations, RCA, CAPAs, and effectiveness checks related to audits, inspections, and quality events. Ensure timely resolution and closure of quality events.

• Bachelor's Degree or equivalent combination of education and experience.
• 5 years of experience in Software Development Life Cycle (SDLC), testing, and validation in a regulated industry and IT auditing (internal and vendors).
• At least 10 years in CRO, pharmaceutical, clinical or related fields.
• Fluent in English.