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 appro...