Sr. Quality Auditor, CAPA Centre of Excellence

IQVIA; Warszawa; On-site; PLN 168,000 - 312,000; Full time

Job summary

IQVIA LLC is seeking a QA leader to manage CAPA processes for significant quality issues and audit responses. You will oversee root-cause analysis, corrective and preventive actions, and effectiveness checks across the eQMS, ensuring timely resolution and regulatory alignment.

The role requires leading CAPA teams, supporting audits, and mentoring staff while promoting a culture of continuous process improvement in a fast-paced environment.

Qualifications

• Bachelor's Degree required; extensive CAPA and GCP knowledge essential.
• Experience leading CAPA investigations and closure.
• Strong root cause analysis, problem solving and mentoring skills.
• Ability to manage complex quality issues with minimal supervision.

Responsibilities

• Lead CAPA management team to drive compliance and improvements.
• Sponsor audits and inspections; ensure investigations, root cause analyses and CAPAs are executed within timelines.
• Collaborate with cross-functional stakeholders to identify process gaps and drive quality process improvements.
• Oversee reporting and documentation of CAPAs in the eQMS with timely effectiveness checks.
• Develop/train on RCA, CAPA management, documentation practices and compliance.
• Advise QA management on audit needs and support internal/external audits.

Skills

CAPA Management

GCP guidelines

Root cause analysis

Leadership

Problem solving

Training/Mentoring

Microsoft Office

Education

Bachelor's Degree

Tools

eQMS

Microsoft Office Suite

Job description

Job Overview

Lead and support effective corrective and preventive action (CAPA) management for significant quality issues (QIs) and audit and inspection responses including the assessment and review of investigations, appropriate root cause analysis and corrective and preventative actions. Provide support to management with insights, analyses and assessment and promotion of compliance with regulations, guidelines, and operating procedures through risk identification and mitigation, and improvement initiatives . Manage the quality assurance oversight of quality issues, audit responses, assignments, training and staff. Oversee and lead team management activities.

Essential Functions

Lead and mentor members of the CAPA management team, with a focus on driving improvement and compliance, ensuring an aligned approach to CAPA management and adherence to regulations and guidelines and providing support as needed. Lead and support CAPA activities for complex QIs and sponsor audits and inspections: assessing investigations, ensuring appropriate root cause analysis is performed, adequate corrective and preventative actions and effectiveness are implemented and followed up within the agreed timelines Collaborate with cross-functional stakeholders to identify process gaps, areas of improvements and ensure the application of quality processes, principles and strategy to support compliance with relevant regulations, GCP guidelines, procedures and sponsor agreements Ensure proper reporting and documentation of CAPAs in the electronic quality management system (eQMS) and that robust corrective and preventative actions and effectiveness checks are tracked and completed within the required timelines Promote a culture of proactive and continuous process improvement by identifying risks and trends, and optimizing the CAPA system and processes. Lead with a spirit of teamwork and collaboration to ensure effective communication among all department stakeholders and staff. Develop and/or provide training and guidance on Root Cause Analysis (RCA), CAPA management, execution, good documentation practices, and compliance adherence Develop and/or improve governing procedures, templates and work instructions, in order to streamline processes and drive compliance Advise Quality Assurance management on system audit needs. Support external and internal audits and inspections of IQVIA including inspections of IQVIA or investigational sites where needed, and ensure a state of inspection readiness at all times.

Qualifications

Bachelor's Degree Extensive knowledge of CAPA Management, GCP guidelines and relevant regulations for the conduct of clinical trials is a must Prior experience in audit and inspection management/support Root cause analysis and quality investigations Able to independently manage complex quality issues with minimal supervision Experience reviewing and driving CAPAs to closure 7 years Quality Assurance experience in pharmaceutical, technical, or related area with a focus on GCP in Clinical Trials. Background in science, healthcare and/or other relevant discipline and a detailed understanding of the clinical trial process and GCP guidelines Possess strong leadership and organizational skills for prioritizing workload and responsibilities. Excellent problem solving and root cause analysis skills. Excellent training and mentoring capabilities. Ability to handle multiple projects and work independently and effectively in a fast-paced changing environment Ability to speak effectively one-to-one, in group settings, with clients, vendors and employees of the organization. Proficient in Microsoft Office applications (Word, Excel)

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is zł 168.100,00 - zł 312.100,00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Thank you for your interest in growing your career with us.