Senior Clinical QA Auditor (GCP)

IQVIA LLC; Madrid; Presencial; EUR 60.000 - 85.000; Jornada completa

Descripción de la vacante

IQVIA LLC is seeking an experienced quality assurance auditor to plan and conduct independent clinical (GCP) audits across IQVIA contracts. You will prepare reports for supervisors, operations staff, management and customers, and advise on interpretations of regulations, guidelines, and procedures.

This role supports the audit lifecycle, drives CAPA planning, and maintains the eQMS. Travel 30-50% mainly in Europe, with 5 years in pharmaceutical QA audits and experience in clinical trial site

Formación

• Certified to conduct audits in accordance with applicable regulations.
• 5 years experience in pharmaceutical or related QA audits.
• Experience in clinical trial investigator site audits preferred.
• Strong problem solving and risk analysis skills.

Responsabilidades

• Plan, schedule, conduct, report and close audit activities across IQVIA contracts.
• Evaluate findings and prepare distributions to staff, management and customers.
• Provide interpretation of regulations and consult project teams.
• Review investigations, RCA, CAPA and EC plans to closure for quality events.
• Maintain eQMS and support QA initiatives and training.

Conocimientos

Audit planning

Regulatory compliance

GCP audits

Root Cause Analysis

CAPA

Quality Assurance

Interpersonal skills

Training capability

Documentation and reporting

Herramientas

eQMS

Descripción del empleo

IQVIA LLC is seeking an experienced quality assurance auditor to plan and conduct independent clinical (GCP) audits across IQVIA contracts. You will prepare reports for supervisors, operations staff, management and customers, and advise on interpretations of regulations, guidelines, and procedures.

This role supports the audit lifecycle, drives CAPA planning, and maintains the eQMS. Travel 30-50% mainly in Europe, with 5 years in pharmaceutical QA audits and experience in clinical trial site