Senior Quality Auditor, CAPA Centre of Excellence

About the role

IQVIA is looking for a Senior Quality Auditor for its CAPA Centre of Excellence in Warsaw. The role leads and supports corrective and preventive action (CAPA) management for significant quality issues and audit and inspection responses, including investigation reviews, root cause analysis and follow-up of corrective actions. It also oversees quality assurance of quality issues, audit responses, assignments, training and staff, and advises management on compliance with regulations, guidelines and operating procedures.

Key responsibilities

• Lead and mentor the CAPA management team, ensuring an aligned approach to CAPA management and adherence to regulations and guidelines.
• Lead and support CAPA activities for complex quality issues and sponsor audits and inspections, ensuring investigations, root cause analysis and corrective actions are completed within agreed timelines.
• Work with cross-functional stakeholders to identify process gaps and apply quality processes and principles to meet regulatory, GCP, procedure and sponsor agreement requirements.
• Ensure proper reporting and documentation of CAPAs in the electronic quality management system (eQMS) and tracking of corrective actions and effectiveness checks.
• 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 site ready for inspection.

Required profile

• Bachelor's degree.
• Extensive knowledge of CAPA management, GCP guidelines and relevant clinical trial regulations.
• 7 years of quality assurance experience in pharmaceutical, technical or a related area, focused on GCP in clinical trials.
• Prior experience in audit and inspection management, quality investigations and driving CAPAs to closure.
• Background in science, healthcare or another relevant discipline with a detailed understanding of the clinical trial process and GCP.
• Strong leadership, organisational, problem-solving and mentoring skills, able to handle multiple projects independently in a fast-paced environment.

Required skills

• Proficiency in Microsoft Office (Word, Excel).
• Root cause analysis and quality investigation skills.

The potential base pay range, annualised, is PLN 168,100 to PLN 312,100, depending on qualifications, location and schedule; incentives, bonuses and other benefits may also apply.