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Senior Compliance Expert

1 week ago

London, Ontario, Canada Alimentiv Full time
Job Overview

The Senior Quality & Compliance Auditor plays a pivotal role in ensuring adherence to regulatory standards and company policies governing clinical research activities. This position requires a deep understanding of regulatory frameworks and risk-based auditing methodologies to drive compliance, enhance quality standards, and mitigate organizational risks.

Audit Responsibilities

- Conduct comprehensive quality and compliance audits in accordance with regulations and standards governing clinical research (including internal audit, vendor audit and site audit) to assess adherence to regulatory standards and company policies.
- Develop and implement strategic, risk-based audit plans to proactively identify areas of concern and ensure regulatory compliance.
- Provide expert consultation on GxP requirements and quality assurance strategies, guiding both internal and external stakeholders.
- Coordinate and conduct clinical sites audit in collaboration with project management teams, ensuring efficient and effective audit execution.
- Analyze and interpret audit findings to author or direct the preparation of detailed audit reports, identifying risks, gaps, and areas for improvement.

Required Skills and Qualifications

- At minimum, qualified candidates will have:
- Education: Honor's Bachelor (minimum).
- Experience: 7-9 Years in Quality auditing function in a contract research organization (CRO), pharmaceutical, biotechnology, or related organization.
- Understanding compliance and risk management issues relating to clinical research, and strong understanding of research ethics and privacy.
- Previous experience leading a team is required.

Benefits

- Salary range: $86,500 - $144,000 a year
- Bonus structure available,
- Work location and conditions: Home-based, Remote, regular office-hours.

About Alimentiv

This position offers an exciting opportunity to work in a dynamic environment with a talented team, dedicated to delivering high-quality services and solutions.