Senior CAPA Quality Auditor, GCP Compliance Lead

Domestiko.Com; Getafe; On-site; EUR 80,000 - 110,000; Full time

Job summary

IQVIA in Madrid, Spain, seeks a Sr. Quality Auditor for GCP CAPA Centre of Excellence to lead CAPA management across significant quality issues and audit responses, ensuring regulatory compliance and robust investigations under ICH-GCP.

You will mentor CAPA teams, oversee investigations, root cause analysis, and the effectiveness of corrective actions, while driving continuous improvement and alignment with sponsor and regulatory requirements.

Qualifications

• Extensive experience in GCP Quality Assurance within clinical trials, CAPA management, ICH-GCP guidelines, and global regulations.
• Audit and inspection management in a GCP-regulated clinical trials environment.
• Hands-on experience conducting root cause analyses and quality investigations under GCP.
• Proven experience driving CAPAs to closure within a GCP clinical research setting.
• Strong understanding of end-to-end clinical trial lifecycle under GCP oversight.
• Experience in managing complex quality and compliance issues with minimal supervision.
• Bachelor's Degree in Life Sciences or related field.
• Excellent problem-solving, risk assessment, and RCA skills in a clinical research/GCP setting.
• Proven ability to train, mentor, and advise stakeholders on GCP quality.

Responsibilities

• Lead CAPA management for the CAPA Centre of Excellence, aligning with regulations and guidelines.
• Lead CAPA activities for complex QIs and sponsor audits: ensure RCAs, corrective actions, and effectiveness within timelines.
• Collaborate with cross-functional stakeholders to identify process gaps and ensure application of quality processes for GCP compliance.
• Ensure proper reporting and documentation of CAPAs in the eQMS with timely close-out of actions.
• Promote a culture of proactive process improvement by identifying risks and trends in CAPA performance.
• Provide training and guidance on RCA, CAPA management, documentation, and compliance.
• Develop and improve governing procedures, templates, and work instructions to streamline processes.
• Advise QA management on system audit needs and readiness for external/internal audits.

Skills

GCP QA

CAPA management

ICH-GCP

Regulatory compliance

Root cause analysis

Team leadership

Training & mentoring

Audit & inspection

Life sciences

Education

Bachelor's in Life Sciences

Tools

eQMS

Job description

IQVIA in Madrid, Spain, seeks a Sr. Quality Auditor for GCP CAPA Centre of Excellence to lead CAPA management across significant quality issues and audit responses, ensuring regulatory compliance and robust investigations under ICH-GCP.

You will mentor CAPA teams, oversee investigations, root cause analysis, and the effectiveness of corrective actions, while driving continuous improvement and alignment with sponsor and regulatory requirements.