Senior QA Auditor – GCP Audits

About the role

The Senior QA Auditor will lead independent Good Clinical Practice (GCP) audits across multiple countries to ensure compliance with regulatory requirements, customer expectations, and IQVIA SOPs. This role involves close interaction with project teams, customers, and regulatory bodies, providing expert guidance and driving continuous improvement.

Key responsibilities

• Plan, schedule, conduct, report, and close audit activities for IQVIA contracts worldwide.
• Evaluate audit findings and distribute detailed reports to operations staff, management, and customers.
• Interpret regulations, guidelines, and policies for project teams and provide consultation on corrective action plans.
• Review and approve investigations, Root Cause Analyses (RCA), Corrective Action Prevention (CAPA) plans, and Effectiveness Checks (EC) and track them to closure.
• Assess policies and procedures for regulatory compliance and recommend process improvements.
• Maintain the electronic Quality Management System (eQMS) and support the audit lifecycle.
• Lead QA initiatives, support process‑improvement projects, and assist in training new QA staff.
• Conduct pre‑inspection visits, host audits/inspections, and support regulatory facility inspections as required.

Required profile

• Certified to conduct audits in Italy according to the Italian Ministry of Health Decree (15 Nov 2011).
• 5 years experience in pharmaceutical or related fields, with at least 3 years in Quality Assurance audits.
• Proven experience in clinical trial investigator site audits; experience in clinical study report or data‑management audits is a plus.
• Strong knowledge of pharmaceutical R&D processes, regulatory environments, and QA procedures.
• Excellent interpersonal, problem‑solving, risk‑analysis, and training capabilities.
• Willingness to travel 30‑50 % across Europe.

Required skills

• eQMS (electronic Quality Management System)
• Microsoft Word
• Microsoft Excel
• Database applications
• Clinical trial audit methodology
• Root Cause Analysis (RCA)
• CAPA (Corrective Action Prevention)