Senior QA Auditor (GCP Audits) - Certified to Audit Sites in Italy
IQVIA · Milan, Italy
QualityFull-timeCompany career page
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Role summary
IQVIA seeks a Senior QA Auditor to plan and conduct independent clinical audits across European sites, assessing compliance with regulations and corporate standards. The role involves audit planning, report preparation, regulatory consultation, and quality issue management across multiple countries.
What they're looking for
- Italian Ministry of Health audit certification (Decree dated 15 Nov 2011)
- 5+ years pharmaceutical or technical experience; 3+ years in Quality Assurance audits
- Experience conducting clinical trial Investigator site audits
- Knowledge of pharmaceutical R&D processes and regulatory environments
- Strong problem-solving, risk analysis, and negotiation skills
- Proficiency with word-processing, spreadsheet, and database applications
- Ability to manage multiple projects and work independently
What you'll be doing
- Plan, schedule, conduct, and report audit activities across IQVIA contract countries to assess regulatory compliance
- Evaluate audit findings and prepare reports for operations, management, and customers
- Provide consultation on regulations, guidelines, and compliance status to project teams
- Review and approve CAPA, RCA, and effectiveness check plans; track closure of quality events
- Support regulatory inspections, mock audits, and customer-initiated audit activities
Compensation€47,500–€71,300 base annually
Privacy & handoff
This role links to IQVIA's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.