Senior Clinical Quality Assurance Auditor

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

Job summary

An innovative research organization is seeking a Senior Clinical Quality Assurance Auditor to enhance oncology research efforts. This remote role involves conducting audits, ensuring compliance with regulations, and fostering a culture of quality. The ideal candidate will have extensive experience in clinical QA, strong analytical skills, and a commitment to excellence. This position offers competitive salary and benefits, including generous vacation and flexible work options, making it an exciting opportunity for professionals looking to make a significant impact in cancer research.

Benefits

Three weeks of vacation

Health, dental, and vision insurance

RRSP matching

Flexible hours

Internet allowance

Work-from-home options

Parental leave top-up

Employee assistance program

Recognition programs

Referral programs

Qualifications

• 5+ years of clinical QA experience in pharma, biotech, or CRO.
• Deep knowledge of GCP, ICH, FDA, and EMA guidelines.

Responsibilities

• Conduct audits of clinical trials and ensure compliance.
• Develop and maintain QA documentation and training.

Skills

Clinical QA Experience

Knowledge of GCP

Analytical Skills

Communication Skills

Leadership Skills

Education

Bachelor's degree in life sciences

Higher degrees in relevant fields

Tools

Word

Excel

PowerPoint

Job description

Senior Clinical Quality Assurance Auditor

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If you are an experienced Senior Clinical Quality Assurance Auditor (internally referred to as Senior Clinical Quality Assurance Manager) 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.

TRIO is seeking a Senior Clinical Quality Assurance Auditor (internally called 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

• Conduct audits of clinical trials, including clinical trial master files, internal processes, investigator sites, CROs, and other entities to ensure compliance with regulations, guidelines, and SOPs.
• Assist in hosting sponsor audits and regulatory inspections, including preparation, conduct, and developing CAPA responses.
• Develop and maintain QA documentation such as audit plans, reports, and inspection readiness plans, ensuring accurate and timely records.
• Provide training on QA practices, regulations, and standards, fostering a culture of quality and compliance.
• Support the development and maintenance of the Quality Management System, including procedures and metrics analysis.
• Identify process improvements, collaborate with teams, and implement best practices for continuous quality enhancement.
• Stay updated on regulations and industry trends, interpret requirements, and ensure organizational compliance.
• Conduct risk assessments, develop mitigation strategies, and implement controls.
• Build strong relationships with internal teams and external partners to facilitate audits, inspections, and regulatory submissions.

Requirements

• Bachelor's degree in life sciences, pharmacy, nursing, or related field; higher degrees are a plus.
• At least 5 years (preferably 8) of clinical QA experience, including audits in pharma, biotech, or CRO environments.
• Deep knowledge of GCP, ICH, FDA, EMA, and regional guidelines.
• Understanding of clinical trial processes, data management, and adverse event reporting.
• Strong analytical, problem-solving, and leadership skills, with the ability to mentor others.
• Excellent communication skills, both written and verbal.
• Attention to detail and commitment to quality.
• Relevant certifications like CQA or CCRP are highly desirable.
• Knowledge of risk management principles and methodologies is a plus.
• Fluent English, with intermediate skills in Word, Excel, PowerPoint.
• Willingness to travel internationally as needed.

What TRIO Offers

• Competitive salary review and growth opportunities.
• Three weeks of vacation plus holiday closure, personal/sick days, volunteer day.
• Comprehensive benefits including health, dental, vision, life insurance, RRSP matching, TFSA, flexible hours, internet allowance, work-from-home options, and more.
• Support for international work, parental leave top-up, employee assistance, recognition, and referral programs.

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

Additional Details

• Seniority level: Mid-Senior
• Employment type: Full-time
• Job function: Quality Assurance
• Industry: Research Services