Senior Quality Auditor, GCP CAPA Centre of Excellence

About the role

IQVIA is looking for a Senior Quality Auditor for its GCP CAPA Centre of Excellence in Madrid. The role leads and supports corrective and preventive action (CAPA) management for significant quality issues and audit and inspection responses, and oversees quality assurance, training and staff. It also advises management on compliance with regulations, guidelines and operating procedures.

Key responsibilities

• Lead and mentor the CAPA management team, driving improvement and compliance with regulations and guidelines.
• Lead and support CAPA activities for complex quality issues and sponsor audits and inspections, including root cause analysis and follow-up of corrective and preventative actions within agreed timelines.
• Work with cross-functional stakeholders to identify process gaps and ensure quality processes and GCP guidelines are applied.
• Ensure CAPAs are reported and documented correctly in the electronic quality management system (eQMS) and that effectiveness checks are tracked and completed on time.
• Promote continuous improvement by identifying risks and trends and optimising CAPA processes.
• Develop and deliver training on root cause analysis, CAPA management, execution and good documentation practices.
• Improve governing procedures, templates and work instructions, and advise Quality Assurance management on system audit needs.
• Support external and internal audits and inspections of IQVIA and investigational sites, keeping the organisation ready for inspection.

Required profile

• Extensive, demonstrable experience in GCP Quality Assurance within clinical trials, including CAPA management and ICH-GCP guidelines.
• Prior audit and inspection management or support experience in a GCP-regulated clinical trials environment; GMP, manufacturing, laboratory or commercial quality experience alone is not sufficient.
• Hands-on experience conducting root cause analyses and quality investigations, and proven experience driving CAPAs to closure.
• Bachelor's degree in Life Sciences, Healthcare, Pharmacy, Nursing or a related scientific discipline.
• Demonstrated ability to manage complex quality and compliance issues with minimal supervision.

Required skills

• Expert knowledge of CAPA management and ICH-GCP guidelines.
• Strong problem-solving, risk assessment and root cause analysis skills.
• Ability to train, mentor and advise stakeholders on GCP quality and compliance requirements.