Senior CAPA & Quality Assurance Lead (GCP/Audit)

IQVIA LLC; Madrid; Presencial; EUR 70.000 - 100.000; Jornada completa

Descripción de la vacante

IQVIA is a leading global provider of clinical research services and healthcare intelligence. We seek a Lead CAPA Manager to oversee corrective and preventive action programs for quality issues, audits and inspections, ensuring robust root cause analysis and timely remediation.

You will mentor the CAPA team, collaborate with cross-functional partners, maintain eQMS documentation, and promote a culture of continuous improvement in compliance with GCP and sponsor agreements.

Formación

• Bachelor's Degree required.
• 7 years Quality Assurance experience in pharma or clinical trials.
• Experience in CAPA management and audit support.
• Strong RCA and problem-solving skills.
• Ability to lead cross-functional teams.
• Proficient in MS Office and quality systems.

Responsabilidades

• Lead CAPA management team and ensure compliance with regulations.
• Oversee investigations, root cause analysis, corrective actions and effectiveness checks.
• Collaborate with stakeholders to identify process gaps and improvements.
• Maintain documentation in the eQMS and ensure timely closure of CAPAs.
• Provide training on RCA and CAPA processes.

Conocimientos

CAPA Management

GCP Guidelines

Audit & Inspection

Root Cause Analysis

Leadership

Quality Assurance

MS Office

Educación

Bachelor's Degree

Herramientas

eQMS

Descripción del empleo

IQVIA is a leading global provider of clinical research services and healthcare intelligence. We seek a Lead CAPA Manager to oversee corrective and preventive action programs for quality issues, audits and inspections, ensuring robust root cause analysis and timely remediation.

You will mentor the CAPA team, collaborate with cross-functional partners, maintain eQMS documentation, and promote a culture of continuous improvement in compliance with GCP and sponsor agreements.