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Senior Quality Assurance Auditor

  • Canada
  • Remote
  • Posted Oct 7, 2026
  • 1 position

$100,000–$140,000 / year

Opens an external site

Employment type
Full-time
Experience level
Senior
Minimum education
Bachelor’s degree
Posting language
English

Job summary

The Senior Quality Assurance Auditor conducts internal audits to ensure compliance with regulatory requirements and clinical research standards. They also lead corrective and preventive action investigations and support regulatory inspections and vendor qualification activities.

Job details

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. You will conduct internal audits and assess adherence to regulatory requirements, quality standards, and established procedures. The position plays a key role in identifying risks, documenting findings, and driving corrective and preventive actions through resolution. You will also support regulatory inspections, client audits, and vendor qualification activities across clinical research operations. The role combines independent work with close collaboration across project teams, quality functions, and external stakeholders. You will contribute to a culture of continuous improvement by supporting training, strengthening processes, and monitoring industry best practices. This position can be performed remotely from anywhere in Canada, offering the opportunity to make a meaningful impact in a quality-focused organization. \n 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. \n How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether? Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1

What you’ll do

The Senior Quality Assurance Auditor conducts internal audits to ensure compliance with regulatory requirements and clinical research standards. They also lead corrective and preventive action investigations and support regulatory inspections and vendor qualification activities.

Requirements

Candidates must hold a bachelor's degree in a relevant field such as health sciences, biology, or mathematics. At least 6 years of quality assurance experience in a clinical research environment is required, along with a strong understanding of GCP and pharmaceutical regulations.

Benefits

  • Medical coverage
  • Dental coverage
  • Vision coverage
  • Life insurance
  • Accidental death & dismemberment insurance
  • Short-term disability coverage
  • Long-term disability coverage
  • Pension plan
  • Paid time off
  • Sick leave
  • Tuition reimbursement
  • Fitness reimbursement
  • Employee Assistance Program
  • Performance-based bonus

Listed skills

  • Quality assurance · Preferred
  • Regulatory Compliance · Preferred
  • Process Improvement · Preferred
  • Conflict Resolution · Preferred
  • Microsoft Office · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

  • Quality assurance
  • Internal auditing
  • Regulatory compliance
  • Clinical research
  • SOP management
  • Corrective and preventive actions
  • Vendor qualification
  • Regulatory inspections
  • GCP guidelines
  • ICH guidelines
  • Risk identification
  • Process improvement
  • Data documentation
  • Analytical skills
  • Conflict resolution
  • Microsoft Office
  • Document Management
  • Mental Concentration
  • General Data Protection Regulation (GDPR)
  • Time Off Management
  • Data Privacy
  • Clinical Research Operations
  • Microsoft Access
  • Research
  • American Society For Quality (ASQ) Certified
  • Auditing
  • Biology
  • Corrective And Preventive Action (CAPA)
  • Certified Quality Auditor
  • Clinical Research
  • Clinical Trials
  • Communication
  • Conflict Resolution
  • Continuous Improvement Process
  • Creative Problem Solving
  • Information Privacy
  • Employee Assistance Programs
  • Health Sciences
  • Good Clinical Practices (GCP)
  • Interpersonal Communications
  • Mathematics
  • Operational Excellence
  • Pharmaceuticals
  • Physics
  • Quality Assurance
  • Quality Management
  • Safety Assurance
  • Process Improvement
  • Coordinating
  • Investigation

Job areas

  • Healthcare
  • Science & Research
  • Consulting
  • Quality Assurance Auditor
  • Physical and Engineering Science Technicians Not Elsewhere Classified
  • Inspectors, Testers, Sorters, Samplers, and Weighers

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