Clinical QA Auditor - GCP Compliance Lead

Sopra Steria; Madrid; On-site; EUR 65,000 - 90,000; Full time

Job summary

IQVIA is seeking a qualified QA Auditor to plan and conduct independent clinical (GCP) audits across Europe, ensuring compliance with regulations, guidelines and SOPs. You will report findings to supervisors and customers and support QA processes across projects.

The role requires travel 30-50% mainly in Europe, 5 years in pharmaceutical/QA audits, and proficiency with regulatory environments. Strong communication and training skills are essential for success.

Qualifications

• Certified to conduct audits in Italy per the Italian Decree of the Ministry of Health (Nov 15, 2011).
• 5 years in pharmaceutical/technical quality assurance audits, 3+ years in audit activities.
• Experience with clinical trial Investigator site audits and study data audits.
• Strong written and oral communication, leadership and training abilities.

Responsibilities

• Plan, schedule, conduct, report and close audit activities across Europe.
• Evaluate findings and prepare reports for operations, management and customers.
• Advise project teams on regulations, guidelines and compliance.
• Review CAPA, RCA and EC plans and track closure for quality events.
• Maintain eQMS and support audit lifecycle in QA initiatives.

Skills

Interpersonal skills

Problem solving

Risk analysis

Negotiation skills

Training capability

Organization

Communication

Multi-project management

Education

Italian audit certification

Tools

MS Office

Job description

IQVIA is seeking a qualified QA Auditor to plan and conduct independent clinical (GCP) audits across Europe, ensuring compliance with regulations, guidelines and SOPs. You will report findings to supervisors and customers and support QA processes across projects.

The role requires travel 30-50% mainly in Europe, 5 years in pharmaceutical/QA audits, and proficiency with regulatory environments. Strong communication and training skills are essential for success.