Quality Management System Lead, Providence Research

Quality Management System Lead, Providence Research

Join to apply for the Quality Management System Lead, Providence Research role at Providence Health Care

The salary range for this position is CAD $38.12/Hr.

- CAD $54.80/Hr. (annual range $74,618 - $107,264 per year).

Providence Research is now accepting applications for a Quality Management Systems Lead to join their team. This is a rare opportunity to play a foundational role in supporting western Canada’s first non‑oncology Phase 1 Clinical Trials Unit at Mount St. Joseph’s Hospital. In this role, you’ll help shape a best‑in‑class quality and compliance framework for early‑phase clinical research while acting as a trusted resource for innovation and continuous improvement across Providence.

Please note that onsite work will be required during the probationary period, with hybrid work and flexible hours available at the manager’s discretion upon completion of said period.

Reporting to the Director, Clinical Research Administration, Providence Research and receiving guidance from the Research Operations Manager, Phase 1 Unit, the Quality Management Systems (QMS) Lead is responsible for strengthening and supporting the quality and compliance framework for all regulated clinical research activities at Providence Research (PR). The role leads the development, implementation, maintenance, and continuous improvement of the QMS to ensure alignment with ICH‑GCP, FDA, EMA, and Health Canada requirements.

The position also supports ethics submissions, regulatory processes, and Clinical Trial Management System (CTMS) operations.

The QMS Lead advances regulatory compliance, inspection readiness, and a culture of continuous improvement across PR. By providing guidance, training, and practical tools to research teams, the role helps ensure high‑quality outcomes and excellence in clinical research conduct.

• Lead and evolve the Quality Management System (QMS) design; implement and continuously improve a robust QMS that ensures Phase 1 clinical trials and other regulated research activities meet ICH‑GCP, Health Canada, FDA, and EMA requirements, supporting inspection readiness and research excellence.
• Drive audit readiness and regulatory compliance; proactively identify quality risks, lead internal and external audit preparation, manage CAPAs, and conduct mock inspections to safeguard participant safety, data integrity, and regulatory compliance.
• Provide regulatory and ethics expertise; support research teams with Health Canada submissions, REB applications and amendments, and ongoing regulatory oversight, acting as a key liaison between investigators, sponsors, and ethics committees.
• Embed a culture of quality through education and systems leadership; develop and deliver QMS, GCP, and compliance training programs, oversee onboarding and refresher education, and lead implementation and optimization of CTMS and eTMF systems to support efficient, high‑quality clinical trial operations.

• Bachelor’s degree in Life Sciences, Quality, Regulatory Affairs or a related discipline, plus a minimum of five (5) years of experience in quality or regulatory specialist roles within a clinical research environment (pharma, biotech, CRO, or academic clinical trials); or an equivalent combination of education, training and experience.
• Certification in Quality (ASQ‑CQA, ISO Lead Auditor), Clinical Research (ACRP, SOCRA), or Regulatory Affairs (RAC) is preferred.

• Strong familiarity with ICH‑GCP, quality systems, FDA, EMA, and Health Canada regulatory frameworks.
• Experience with audits, inspections, CAPA management, and document control.
• Demonstrated experience developing and delivering staff education and training programs.
• Ability to draft and review ethics submissions.
• Ability to handle confidential information with discretion.
• Excellent organizational skills and attention to detail.
• Effective communication, facilitation, and presentation skills.
• Ability to influence research culture by combining quality oversight with staff development.
• Ability to work independently and collaboratively in a fast‑paced environment.
• Proficiency…