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.