Senior CAPA & GCP Quality Auditor

Neotalent Conclusion; Madrid; On-site; EUR 80,000 - 110,000; Full time

Job summary

IQVIA is seeking a Sr. Quality Auditor with GCP CAPA expertise to lead CAPA management for significant quality issues and to oversee audit and inspection responses across multiple sites, including investigations and root cause analysis.

This role ensures compliance with ICH-GCP guidelines and sponsor agreements while driving continuous improvement. You will mentor the CAPA team, support management with risk assessment, and collaborate with stakeholders to implement effective corrective and

Qualifications

• Extensive experience in GCP Quality Assurance within clinical trials.
• Experience managing CAPA processes in a GCP-regulated environment.
• Strong root cause analysis and investigation skills in clinical research.

Responsibilities

• Lead and mentor CAPA management team to drive improvement and compliance.
• Oversee CAPA activities for complex QIs and sponsor audits/inspections with timely actions.
• Collaborate with cross-functional stakeholders to ensure application of quality processes and GCP guidelines.
• Ensure proper reporting of CAPAs in eQMS with timely effectiveness checks.
• Promote proactive process improvements by identifying risks and trends.

Skills

CAPA management

GCP Quality Assurance

ICH-GCP

Audit & inspection management

Root Cause Analysis

Cross-functional collaboration

Education

Bachelor's Degree in Life Sciences or related field

Tools

eQMS

Job description

IQVIA is seeking a Sr. Quality Auditor with GCP CAPA expertise to lead CAPA management for significant quality issues and to oversee audit and inspection responses across multiple sites, including investigations and root cause analysis.

This role ensures compliance with ICH-GCP guidelines and sponsor agreements while driving continuous improvement. You will mentor the CAPA team, support management with risk assessment, and collaborate with stakeholders to implement effective corrective and