Senior Clinical QA Auditor – Investigator Site Audits Lead

IQVIA Argentina; Milano; Ibrido; EUR 48.000 - 71.000; Tempo pieno

Descrizione del lavoro

IQVIA Quality Assurance is seeking an experienced auditor to independently lead audit activities across a diverse portfolio of clinical research programs, primarily Investigator Site Audits (ISAs). You will evaluate compliance with GCP, regulations, and IQVIA SOPs, and report findings to management and customers.

The role requires Italy-based certification, 30–50% travel across Europe, and 5 years in pharma QA audits.

Competenze

• Certified to conduct audits in Italy in accordance with the Italian Decree of the Ministry of Health dated 15 November 2011.
• Experience in the conduct of clinical trial Investigator Site Audits.
• Travel 30-50% mainly in Europe.
• 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance Audits.
• Extensive knowledge of pharmaceutical research and development processes, regulatory environments, and quality assurance processes and procedures.

Mansioni

• Plan, schedule, conduct, report and close audit activities in any of the countries involved with IQVIA contracts to assess compliance with applicable regulations/guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions.
• Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.
• Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
• Provide consultation to customers and monitors in interpretation of audit observations and formulation of CAPA plans.
• Review, approve investigations, RCA, CAPA and EC plans and track till closure for quality events arising from Audits; and from Quality Issues, Inspections or during similar QA activities as assigned.
• Perform pre-inspection visits at sites.

Conoscenze

Audit planning

Regulatory knowledge

Interpersonal skills

Communication

Risk analysis

Training capability

Independent work

Formazione

Quality Assurance/Pharma degree

Descrizione del lavoro

IQVIA Quality Assurance is seeking an experienced auditor to independently lead audit activities across a diverse portfolio of clinical research programs, primarily Investigator Site Audits (ISAs). You will evaluate compliance with GCP, regulations, and IQVIA SOPs, and report findings to management and customers.

The role requires Italy-based certification, 30–50% travel across Europe, and 5 years in pharma QA audits.