[Hiring] Principal Auditor Quality Assurance @ICON plc

Role Description

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/or regulatory authorities and be accountable for managing confirmed Quality Event (QE) case through the investigation process including root cause analysis.

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

• 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.

Qualifications

• 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 communication.
• Strong background in continuous improvement methodology (i.e., Lean Six Sigma) preferred.

Benefits

• Various annual leave entitlements.
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance.
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.