Senior QA Auditor (GCP Audits) - Certified to Audit Sites in Italy

About the role

iQVIA is looking for a Senior QA Auditor certified to audit clinical research sites in Italy. The role plans and conducts independent GCP audits, prepares and distributes audit reports, advises project teams and customers on regulations and policies, and supports management in assessing compliance. It involves leading audit activities across a diverse portfolio of clinical research programs and collaborating with global teams.

Key responsibilities

• Plan, schedule, conduct, report and close audits in countries covered by iQVIA contracts, checking compliance with regulations, guidelines, customer requirements, iQVIA SOPs and project-specific instructions.
• Evaluate findings and prepare and distribute reports to operations staff, management and customers.
• Advise project teams and customers on regulations, compliance status and CAPA planning.
• Review, approve and track investigations, root cause analyses, CAPAs and effectiveness checks until closure.
• Perform pre-inspection site visits and evaluate policies and procedures for compliance.
• Maintain the electronic quality management system (eQMS) and support the audit lifecycle.
• Lead, join or support QA and process improvement projects; depending on needs, train new QA staff, present compliance training and host customer audits and mock regulatory inspections.

Required profile

• Certified to conduct audits in Italy under the Italian Ministry of Health decree of 15 November 2011.
• Experience conducting clinical trial investigator site audits.
• 5 years in pharmaceutical, technical or related fields, of which 3 years in QA audits.
• Extensive knowledge of R&D processes, regulatory environments and QA procedures.
• Travel 30-50%, mainly in Europe.

Required skills

• Strong problem-solving, risk analysis and negotiation skills.
• Knowledge of word processing, spreadsheet and database applications.

The stated base pay range is EUR 47,500 to EUR 71,300 per year, depending on qualifications, location and schedule; incentives and other benefits may also apply.