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.

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