Senior QA Auditor - GCP Audits

About the role

IQVIA is looking for a Senior QA Auditor to plan and carry out independent clinical (GCP) audits across the countries involved in IQVIA contracts. The role covers assessing compliance with regulations, guidelines, customer requirements and IQVIA's own procedures, reporting findings and supporting management in promoting and assessing compliance.

Key responsibilities

• Plan, schedule, conduct, report and close audit activities in the countries covered by IQVIA contracts, against regulations, guidelines, customer requirements, IQVIA SOPs and project-specific instructions.
• Evaluate audit findings and prepare and distribute reports to operations staff, management and customers.
• Advise project teams and customers on regulations, guidelines, compliance status and corrective action plans.
• Review, approve and track investigations, root cause analyses, CAPA and effectiveness check plans until closure for quality events arising from audits, inspections or quality issues.
• Evaluate policies and procedures for compliance and recommend process improvements.
• Maintain the electronic quality management system (eQMS) and support the audit lifecycle.
• Lead or support QA initiatives, train new QA staff, give presentations on compliance and, where assigned, manage quality issues, run pre-inspection visits and mock regulatory inspections.

Required profile

• Certified to conduct audits in Italy under the Italian Ministry of Health decree of 15 November 2011.
• 5 years of experience in pharmaceutical, technical or related fields, including 3 years in quality assurance audits.
• Experience conducting clinical trial investigator site audits; clinical study report and data management audit experience preferred.
• Travel 30-50%, mainly in Europe.

Required skills

• Knowledge of pharmaceutical R&D processes, regulatory environments and quality assurance procedures.
• Word processing, spreadsheets and database applications.
• Strong problem-solving, risk analysis, negotiation and training skills, with good organisation and communication.