Global Lead Clinical QA Auditor - GCP & ISA

IQVIA LLC; Milano; In loco; EUR 48.000 - 71.000; Tempo pieno

Descrizione del lavoro

IQVIA is seeking a QA Auditor to independently lead the full audit lifecycle for Investigator Site Audits across a diverse portfolio of clinical research programs. The role requires coordinating with global teams, evaluating findings, and preparing CAPA plans while ensuring adherence to GCP and regulatory requirements.

The position involves travel 30–50% mainly in Europe, with a strong emphasis on quality compliance and continuous improvement within a global quality organization.

Competenze

• Certified to conduct audits in Italy according to regulatory decree.
• Experience in ISA audits for clinical trials.
• Willingness to travel 30–50% mainly in Europe.

Mansioni

• Plan, schedule, conduct, report and close audit activities across IQVIA contracts.
• Evaluate findings and prepare reports to stakeholders.
• Provide interpretation of regulations, guidelines, and quality policies.

Conoscenze

Interpersonal skills

Problem solving

Negotiation

Training skills

Organizational skills

Communication

MS Office

Formazione

Audit certification (Italy Decree 15 Nov 2011)

Experience in clinical trial Investigator Site Audits

Strumenti

eQMS

Descrizione del lavoro

IQVIA is seeking a QA Auditor to independently lead the full audit lifecycle for Investigator Site Audits across a diverse portfolio of clinical research programs. The role requires coordinating with global teams, evaluating findings, and preparing CAPA plans while ensuring adherence to GCP and regulatory requirements.

The position involves travel 30–50% mainly in Europe, with a strong emphasis on quality compliance and continuous improvement within a global quality organization.