Senior QA Auditor - GCP Audits

About the role

The Senior QA Auditor will independently plan, conduct, and close Good Clinical Practice (GCP) audits across multiple countries to ensure compliance with regulations, guidelines, and IQVIA SOPs. The role involves reporting findings, providing regulatory interpretation, and supporting corrective actions for quality events.

Key responsibilities

• Plan, schedule, execute, and close audit activities for IQVIA contracts in Europe.
• Prepare and distribute audit reports to operations staff, management, and customers.
• Interpret regulations, guidelines, and corporate policies for project teams and customers.
• Review, approve, and track investigations, Root Cause Analyses (RCA), CAPA, and Effectiveness Checks (EC) until closure.
• Maintain the electronic Quality Management System (eQMS) throughout the audit lifecycle.
• Lead or support QA initiatives and process‑improvement projects.
• Assist in training new Quality Assurance staff and present educational programs.
• Perform pre‑inspection visits, host audits/inspections, and support regulatory facility inspections as required.

Required profile

• Certified to conduct audits in Italy according to the Ministry of Health Decree (15 Nov 2011).
• 5 + years experience in pharmaceutical or technical fields, with at least 3 years in Quality Assurance audits.
• Experience conducting clinical trial investigator site audits; clinical study report/data‑management audit experience preferred.
• Willingness to travel 30‑50 % across Europe.
• Strong knowledge of pharmaceutical R&D processes, regulatory environments, and quality‑assurance procedures.

Required skills

• Microsoft Word
• Microsoft Excel
• Database applications
• Electronic Quality Management System (eQMS)