Senior Quality Assurance Auditor

Accountabilities

• 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, including tracking records, database updates, review obligations, and follow-up activities.

• Support client audits and regulatory inspections by coordinating preparation activities and providing quality assurance expertise.

• Independently perform vendor qualification assessments, coordinate assessment activities, and follow up on identified observations.

• Deliver training on quality assurance procedures and support the consistent application of QA practices across teams.

• Follow up with project and study teams to ensure required study-specific training, project kick-off activities, and sponsor-specific procedures are properly completed and documented.

• Research industry trends, regulatory developments, and quality best practices while participating in relevant professional development and industry activities.

• Identify opportunities to strengthen quality systems, improve processes, and promote consistent compliance across clinical research activities.

Requirements

• 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; significant and sustained performance in a relevant non-QA role may be considered as an alternative.

• Quality auditor certification through ASQ, ISO, or an equivalent organization is preferred.

• Experience supporting the preparation for or hosting of regulatory inspections is preferred, ideally with at least one year of relevant exposure.

• Strong knowledge of clinical trial processes, procedures, and operational practices.

• Comprehensive understanding of pharmaceutical and clinical research regulations, including requirements from authorities such as the FDA, Health Canada, and the European Medicines Agency.

• 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, with strong attention to detail and the ability to identify inconsistencies.

• Strong conflict-resolution and interpersonal skills, with the ability to communicate effectively with professionals and administrative personnel at all organizational levels.

• Highly organized, capable of managing multiple priorities, and able to maintain concentration and accuracy over extended periods.

• Demonstrated commitment to quality, compliance, continuous improvement, and timely delivery of high-quality work.

• Strong proficiency with Microsoft Office applications.

Benefits

• Estimated annual salary range of $100,000–$140,000.

• Medical, dental, and vision coverage.

• Life and accidental death & dismemberment (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.

• Workplace accommodations and an inclusive environment for candidates with disabilities.