Job Description Summary

The Good Clinical Practice (GCP) Quality Assurance (QA) Auditor is crucial in ensuring that clinical trials are conducted ethically, with integrity, and in compliance with regulatory requirements and GCP guidelines. This role is responsible for providing QA auditing for the PDx business. This role will have a focus on auditing and Global Compliance support to R&D & GCP activities but also to the GMP manufacturing sites, GDP, PV, and GLP related functions. This role reports directly to the Global Compliance Quality Assurance R&D / GCP Leader Pharmaceutical Diagnostics.

The role will oversee, coordinate and lead audits on behalf of PDx QRA with a focus on GCP and R&D functions including to but not limited to CRO’s, Investigator sites, Centralised Labs and specialist Non Clinical Labs. In this role insights and industry trends are to be proactively shared within PDx to ensure continued compliance and early identification of areas for continuous improvement.

This role will provide analyses of audits / trends and support in the assessment and promotion of compliance within all PDx departments including global clinical, non clinical and R&D. This role will be aware of changes to regulations, guidelines, and provide support and QA oversight for any necessary updates to operating procedures, risk assessments and change controls for process changes as well as productivity / efficiency improvement initiatives.

Job Description

Key responsibilities/essential functions include:

• Compliance Oversight: The QA Auditor is responsible for ensuring that all aspects of the clinical trial comply with relevant regulations, guidelines, and standard operating procedures (SOPs), including but not limited to the International Council for Harmonisation (ICH) GCP guidelines.
• Audit Planning and Execution: They plan, conduct, and report on audits of clinical trial activities, sites, and documents to verify compliance with GCP standards. This involves reviewing study protocols, informed consent forms, case report forms, regulatory submissions, and other essential documents.
• Maintenance of the annual internal and vendor audit schedules and their updates.
• Investigation of Non-Compliance: If any instances of non-compliance or deviations from GCP are identified during audits or through other means, the QA Auditor conducts thorough investigations. This includes root cause analysis, corrective and preventive action (CAPA) development, and implementation to address and prevent recurrence of issues.
• Ensure all identified actions / observations are appropriate to remediate the deficiency and are completed in a timely manner and complete reviews to ensure effectivity.
• Perform QA review and approval of audit related documents
• Training and Education: They may provide training to clinical trial personnel on GCP requirements, SOPs, and best practices to ensure understanding and adherence to regulatory standards.
• Documentation Review and Management: QA Auditors review and maintain documentation related to clinical trial activities, ensuring accuracy, completeness, and compliance with regulatory requirements. This includes maintaining audit trails, investigation reports, and CAPA documentation.
• Risk Assessment: Support risk assessments of clinical trial processes and systems to identify potential areas of non-compliance or risk to data integrity, patient safety, or regulatory compliance. Work with the customer to undertake risk analysis of systems and processes, to propose process / functional audits.
• Vendor Oversight: If applicable, they also oversee vendors and subcontractors involved in clinical trial activities to ensure they meet GCP standards and contractual obligations.
• Collaboration and Communication: QA Auditors often collaborate with various stakeholders, including clinical trial sponsors, investigators, regulatory authorities, and internal departments, to address compliance issues and drive continuous improvement in clinical trial quality.
• Stay Updated with Regulations: They stay abreast of updates to relevant regulations, guidelines, and industry best practices to ensure ongoing compliance and adaptation of quality assurance processes.
• Quality Metrics and Reporting: QA Auditors may develop and monitor key quality metrics to assess the effectiveness of quality management systems and report findings to senior management and regulatory authorities as required. Conduct trend analysis of audit and other quality related data, provide to internal / external stakeholders as agreed
• Support regulatory inspections and customer audits as a functional QA subject matter expert
• Participates in the quality management system (QMS) improvements.

• Overall, the rol