Opening - Senior Auditor Clinical Trial Quality Assurance

Role & responsibilities

CTQA Auditor is responsible for planning, conducting, and reporting on internal and external audits of clinical trials to ensure compliance with regulatory standards, Good Clinical Practice (GCP), and organizational policies. This role requires a seasoned professional who can identify quality risks, recommend corrective actions, and provide strategic guidance to enhance the quality management system.

• Investigator site audits
• Vendor audits (CROs, laboratories, etc.)
• Trial master file (TMF) audits
• Process/system audits (e.g., SOP compliance, GCP compliance)
• Assess compliance with GCP, ICH guidelines, FDA/EMA regulations, and other applicable standards.
• Develop detailed audit plans, audit checklists, and risk-based audit strategies.

• Prepare comprehensive audit reports detailing findings, observations, and corrective action recommendations.
• Collaborate with stakeholders to ensure timely resolution and implementation of corrective and preventive actions (CAPAs).
• Conduct CAPA verification to confirm effectiveness.