Principal Auditor Quality Assurance

Principal Auditor Quality Assurance

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

The Issue Lead / Principal Auditor Quality Assurance will be responsible for driving QE case management, ensuring that investigations are conducted thoroughly within timelines and compliance requirements, overseeing the efficiency of the process by which Pfizer conducts GCP investigations, and leveraging data to assess the efficiency / performance of the appropriate teams to perform interventions as needed. The Issue Lead will also triage submitted cases to ascertain if the Quality Event (QE) threshold has been met and assess cases to determine if they need expedited reporting to senior management and/regulatory authorities and be accountable for managing confirmed Quality Event (QE) case through the investigation process including root cause analysis.

What You Will Do:

Your focus will be on coordinating quality assurance and compliance delivery, resolving issues, and developing team capability.

Key responsibilities include:

• Leading and conducting comprehensive audits of clinical trial processes, systems, and documentation to ensure compliance with regulatory standards and guidelines.
• Collaborating with cross-functional teams to identify areas for improvement in quality assurance processes and practices.
• Developing and implementing audit plans and strategies to assess the effectiveness of quality management systems.
• Providing expert guidance and recommendations to stakeholders on quality assurance best practices and regulatory requirements.
• Contributing to the continuous improvement of quality assurance programs and initiatives.
• Quality Event Assessment and Investigation.
• Notification to Management.
• Root Cause Analysis / Gap Analysis / Due Diligence.
• Process Analysis and Improvement.
• CAPA Plan Development and Management.
• Risk Mitigation Tracking.

Your Profile:

You will have solid quality assurance and compliance experience, with the ability to manage competing priorities and develop your team.

• 7+ years’ experience or equivalent with BS or 6+ years’ experience or equivalent with MBA/MS
• Minimum of 5 years of pharmaceutical experience with solid experience in data management, operational aspects, GCP Quality, GxP Quality, and/or regulatory
• Regulatory inspection experience • Process and system management experience
• Detailed knowledge of clinical trial processes and relationships required
• Knowledge of GCP requirements and applicable SOPs and regulations
• Project management, administrative, and technical capabilities are required, as well as effective verbal
• Strong background in continuous improvement methodology (i.e., Lean Six Sigma) preferred.

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What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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