Senior Clinical Quality Assurance Auditor

Translational Research in Oncology; Montreal; Remote; CAD 80,000 - 110,000; Full time

Job summary

A leading clinical research organization is seeking a Senior Clinical Quality Assurance Auditor to join their Quality Assurance team. This remote role involves conducting audits, ensuring compliance with regulations, and fostering a culture of quality. Ideal candidates will have extensive QA experience in pharma or biotech, strong analytical skills, and a commitment to quality. The position offers competitive salary and comprehensive benefits.

Benefits

Competitive salary review

Vacation and paid holidays

Comprehensive health benefits

Retirement plans with matching

Flexible work arrangements

Qualifications

• Minimum 5 years of clinical QA experience, preferably 8.
• Deep knowledge of GCP, ICH, FDA, EMA regulations.

Responsibilities

• Conduct audits of clinical trial master files and internal processes.
• Develop and maintain audit plans and documentation.
• Provide guidance on QA practices and regulations.

Skills

Analytical

Problem Solving

Leadership

Communication

Attention to Detail

Education

Bachelor's degree in life sciences

Advanced degrees

Tools

Word

Excel

PowerPoint

Job description

Job Title: Senior Clinical Quality Assurance Auditor (Internally referred to as Senior Clinical Quality Assurance Manager)

If you are an experienced Senior Clinical Quality Assurance Auditor who is passionate about oncology research and looking to join a highly skilled team, TRIO is the place for you!

Translational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing future cancer treatments today.

Position Overview

TRIO is seeking a Senior Clinical Quality Assurance Auditor (internally referred to as Senior Clinical Quality Assurance Manager) to join our Quality Assurance team. Reporting to the Senior Director of Quality Assurance, this role is remote-based in Canada.

Responsibilities

1. Conduct Audits: Plan and perform audits of clinical trial master files, internal processes, investigator sites, CROs, and other entities to ensure compliance with regulations, guidelines, and SOPs.
2. Host Audits/Inspections: Support sponsor audits and regulatory inspections, including preparation, conduct, and developing CAPA responses.
3. Quality Assurance Documentation: Develop and maintain audit plans, reports, inspection readiness plans, and other documentation, ensuring accurate records of findings and corrective actions.
4. Training and Education: Provide guidance on QA practices, regulations, and standards, fostering a culture of quality and compliance.
5. Quality Management System: Assist in developing and maintaining the organization's QMS, including procedures and metrics analysis.
6. Process Improvement: Collaborate with teams to identify and implement process enhancements for clinical quality systems.
7. Regulatory Compliance: Stay informed about current regulations and ensure organizational adherence.
8. Risk Assessment: Conduct risk assessments, develop mitigation strategies, and implement controls.
9. Collaboration and Communication: Build relationships with internal teams and external partners to facilitate audits, inspections, and submissions.

Requirements

• Bachelor's degree in life sciences, pharmacy, nursing, or related field; advanced degrees are a plus.
• Minimum 5 years (preferably 8) of clinical QA experience, including audits and inspections in pharma, biotech, or CRO settings.
• Deep knowledge of GCP, ICH, FDA, EMA regulations.
• Strong understanding of clinical trial processes.
• Excellent analytical, problem-solving, and leadership skills.
• Effective communicator, both written and verbal.
• Attention to detail and commitment to quality.
• Certifications like CQA or CCRP are highly desirable.
• Knowledge of risk-based quality management principles is a plus.
• Fluent in English; proficient in Word, Excel, PowerPoint.
• Willingness to travel internationally as needed.

What TRIO Offers

• Competitive salary review and growth opportunities.
• Vacation, paid holidays, personal/sick days, volunteer days.
• Comprehensive benefits including health, dental, vision, life insurance.
• Retirement plans with matching, flexible work arrangements, and allowances.
• Support for international work, parental leave, employee assistance, recognition, and referral programs.

Pay Range: $80,000 - $110,000, depending on experience and qualifications.

Teamwork · Passion · Integrity · Innovation