Senior QA Auditor - GCP Audits

About the role

The Senior QA Auditor will plan, schedule, conduct and close independent clinical (GCP) audits across multiple countries to ensure compliance with regulations, guidelines, IQVIA SOPs and project‑specific instructions. The role involves preparing audit reports, providing regulatory interpretation, and supporting corrective actions.

Key responsibilities

• Plan, schedule, conduct, report and close audit activities for IQVIA contracts.
• Evaluate audit findings and distribute reports to operations staff, management and customers.
• Provide interpretation and consultation on regulations, guidelines, compliance status and policies.
• Review and approve investigations, Root Cause Analyses, CAPA and Effectiveness Checks, tracking them to closure.
• Assess policies and procedures for regulatory compliance and recommend continuous improvements.
• Maintain the electronic Quality Management System (eQMS) throughout the audit lifecycle.
• Lead or support QA initiatives, process‑improvement projects and training of new QA staff.
• May manage quality issues, present educational programs and assist with pre‑inspection visits, audits, inspections and mock regulatory inspections.

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 technical fields, with at least 3 years in Quality Assurance audits.
• Experience conducting clinical trial investigator site audits; experience with clinical study report/data‑management audits is preferred.
• Travel 30‑50 % mainly within Europe.
• Strong knowledge of pharmaceutical R&D processes, regulatory environments and quality‑assurance procedures.

Required skills

• Proficiency with word‑processing applications.
• Proficiency with spreadsheet applications.
• Proficiency with database applications.