Senior GCP CAPA Quality Leader - Centre of Excellence

IQVIA; Lisboa; On-site; EUR 90,000 - 130,000; Full time

Job summary

IQVIA is seeking a senior GCP Quality Assurance professional to lead CAPA management for significant quality issues and audit responses. You will assess investigations, perform root cause analyses, implement corrective actions, and ensure timely compliance with regulations.

Collaborating with cross-functional teams, you will drive CAPA effectiveness, maintain eQMS documentation, and promote continuous process improvements within a GCP environment.

Qualifications

• Extensive GCP QA experience in clinical trials with CAPA, ICH-GCP and global regs.
• Audit/inspection management experience in a GCP-regulated setting required.
• Experience performing root cause analyses and investigations under GCP.
• Proven track record driving CAPAs to closure in a GCP environment.
• Understanding end-to-end clinical trial lifecycle under sponsor/CRO oversight.
• Bachelor's degree in Life Sciences, Healthcare, Pharmacy, Nursing, or related field.
• Strong problem-solving and risk assessment skills in clinical research.
• Ability to train and mentor stakeholders on GCP requirements.

Responsibilities

• Lead CAPA management activities for CAPAs related to significant quality issues and audits.
• Assess investigations, ensure robust root cause analysis and appropriate corrective actions.
• Collaborate with cross-functional stakeholders to improve quality processes and compliance.
• Ensure CAPAs are documented in the electronic quality management system (eQMS) and tracked to closure.
• Promote proactive continuous process improvement by identifying risks and trends.
• Provide training on Root Cause Analysis, CAPA, and good documentation practices.
• Advise management on system audit needs and readiness for inspections.
• Support external and internal audits and inspections as required.

Skills

CAPA management

GCP QA

ICH-GCP guidelines

Audit & inspection management

Root cause analysis

Training & mentoring

Regulatory compliance

Education

Bachelor's Degree in Life Sciences or related

Tools

eQMS

Job description

IQVIA is seeking a senior GCP Quality Assurance professional to lead CAPA management for significant quality issues and audit responses. You will assess investigations, perform root cause analyses, implement corrective actions, and ensure timely compliance with regulations.

Collaborating with cross-functional teams, you will drive CAPA effectiveness, maintain eQMS documentation, and promote continuous process improvements within a GCP environment.