Quality Assurance Auditor

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Quality Assurance Auditor based in Canada.

This role is an opportunity to contribute to quality, compliance, and operational excellence within a global clinical research environment.

• Conduct scheduled internal audits to evaluate compliance with applicable regulatory requirements, clinical research standards, and established SOPs
• Document, communicate, and report audit findings accurately and within required timelines
• Lead corrective and preventive action investigations and monitor compliance issues through successful resolution
• Maintain governing and procedural documentation
• Support client audits and regulatory inspections
• Independently perform vendor qualification assessments
• Deliver training on quality assurance procedures
• Follow up with project and study teams
• Research industry trends, regulatory developments, and quality best practices
• Identify opportunities to strengthen quality systems

• Bachelor’s degree in health sciences, physics, biology, mathematics, or a related discipline
• At least 6 years of quality assurance experience within a clinical research environment
• Quality auditor certification through ASQ, ISO, or an equivalent organization is preferred
• Experience supporting regulatory inspections is preferred
• Strong knowledge of clinical trial processes, procedures, and operational practices
• Comprehensive understanding of pharmaceutical and clinical research regulations, including FDA, Health Canada, and EMA
• Strong knowledge of ICH and Good Clinical Practice (GCP) guidelines
• Solid understanding of QA and QC processes, procedural document management, auditing methodologies, and training practices
• Excellent analytical, investigative, and creative problem-solving skills
• Strong conflict-resolution and interpersonal skills
• Highly organized, capable of managing multiple priorities
• Strong proficiency with Microsoft Office applications

• Estimated annual salary range of $100,000–$140,000
• Medical, dental, and vision coverage
• Life and AD&D insurance
• Short-term and long-term disability coverage
• Pension plan
• Generous paid time off and sick leave
• Tuition reimbursement
• Fitness reimbursement
• Employee Assistance Program (EAP)
• Eligibility for a performance-based bonus
• Remote work opportunity from anywhere in Canada