Quality Management System Lead, Providence Research

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 Canadas first non-oncology Phase 1 Clinical Trials Unit at Mount St. Josephs this role youll 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 being onsite will be required during the probationary period with hybrid work and flexible hours available at managers 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. Working closely with clinical operations and external partners the QMS Lead ensures that studies are compliant inspection-ready and conducted according to established quality standards. The position also leads educational and training initiatives to embed principles of compliance data integrity and quality throughout the research environment.

Your duties will include:

• 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.

Education Training and Experience

• Bachelors 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.

Skills and Abilities

• 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 with QMS tools CTMS eTMF systems and Microsoft Office Suite.
• Physical ability to perform the duties of the position.

• A competitive salary: The salary range for this position is $74618 - $107264 per year depending on experience.
• Growth opportunities: We welcome individuals at all stages of their career offering opportunities for professional development and growth.
• State-of-the-art facilities: The new St. Pauls Hospital and health campus will be the most innovative approach to the delivery of integrated care in B.C. and Canada designed to appropriately address the future health needs of patients families and our communities. From hospital care to primary and community health solutions the new St. Pauls Hospital and health campus will continue to lead innovations in care research and teaching. The new St. Pauls Hospital is expected to open in 2027.
• Inclusive culture: We respect the diversity dignity and interdependence of all persons. We value the cultural richness that our diverse workforce brings to the care of our equally diverse population of patients and residents.
• Meaningful impact: You will have the opportunity to work for an organization that is deeply committed to safeguarding of our surrounding environment by contributing to high quality care while promoting sustainable practices in your everyday work.
• A comprehensive health benefits package including dental vision and life insurance as well as pension.
• Hybrid workand flexibile hours available at managers discretion

Your day to day:

• Provides strategic leadership in maintaining monitoring and continuously improving the Quality Management System (QMS) to ensure that all clinical trial activities are conducted in compliance with global regulatory standards institutional policies and best practices.
• Oversees the development implementation and maintenance of controlled documents including standard operating procedures (SOPs) forms and templates ensuring alignment with Good Clinical Practice (GCP) guidelines and organizational requirements.
• Promotes and embeds a culture of quality across all research teams by integrating QMS principles into daily operations and fostering accountability for compliance and excellence.
• Leads comprehensive quality risk assessments identifies potential areas of vulnerability and implements robust mitigation strategies to safeguard research integrity and participant safety.
• Monitors evolving regulatory requirements at the international national and institutional levels interprets their implications for ongoing and planned studies and communicates necessary changes to research teams in a timely and actionable manner.
• Ensures that all clinical studies adhere to ICH-GCP standards and organizational QMS requirements through proactive oversight guidance and continuous evaluation.
• Designs develops and delivers educational programs for the research community including presentations workshops and seminars focused on research quality regulatory compliance and best practices in clinical trial conduct.
• Creates and implements onboarding programs for new staff covering QMS orientation ICH-GCP principles and ethics requirements ensuring a strong foundation for compliance and quality.
• Organizes and facilitates ongoing refresher training sessions to keep staff informed of SOP updates regulatory changes and lessons learned from audits and inspections.
• Provides specialized role-specific training for clinical operations Quality Assurance (QA) regulatory staff and vendors to ensure competency and compliance within their respective functional areas.
• Develops and maintains comprehensive training materials job aids and e-learning modules and ensure accurate documentation of training records within the QMS.
• Oversees training compliance for the Phase 1 Clinical Trials Unit ensuring all personnel meet regulatory and institutional competency requirements.
• Provides expert guidance and hands-on support to the research community in preparing and submitting regulatory applications to Health Canada ensuring accuracy completeness and compliance with applicable regulations.
• Prepares and coordinates submissions to Research Ethics Boards (REB) including initial applications amendments and continuing reviews while maintaining clear and timely communication with investigators and ethics committees.
• Acts as a liaison between research teams ethics committees (IRB/REB) and sponsors during all phases of study approval and oversight facilitating efficient resolution of queries and ensuring adherence to ethical and regulatory standards.
• Leads institutional efforts to achieve and maintain audit and inspection readiness by developing and implementing comprehensive preparation plans for internal and external reviews.
• Manages post-audit activities including tracking and reporting corrective and preventive actions (CAPAs) deviations and follow-up measures to ensure timely resolution and continuous improvement.
• Conducts mock audits and inspection-readiness drills to assess preparedness identifies gaps and provides targeted training and resources to research teams.
• Leads the implementation and validation of the Clinical Trial Management System (CTMS) and other computerized systems for the Phase 1 Unit and affiliated research teams ensuring functionality compliance and user adoption.
• Oversees the maintenance and integrity of the Trial Master File (TMF/eTMF) and Investigator Site Files ensuring accurate complete and timely documentation throughout the study lifecycle.
• Provides expert guidance and practical training to study teams on protocol adherence informed consent processes data integrity and documentation standards reinforcing compliance and operational excellence.

Who We Are:

Providence Health Care is one of the largest faith-based health care organizations in Canada. For the people at Providence living our Mission Vision and Values means providing British Columbians with compassionate socially just exceptional and innovative care every day.

From our humble roots 129 years ago Providence Health Care has grown into a globally recognized leader in research teaching and care. As individuals within a mission-driven organization we choose to be part of PHC because we value its long-standing dedication to social justice and compassionate care its active efforts to advance environmental sustainability and planetary health and its meaningful engagement in the process of Truth and Reconciliation with Indigenous Peoples.

Curious about working at PHC and the culture of our teams Check out the video below to learn more and meet some of the members of the team youd be joining:

We acknowledge that Providence Health Care and the new St. Pauls Hospital site is located on the traditional ancestral and unceded territory of the Coast Salish Peoples including the territories of the xʷməθkwəyəm (Musqueam) Skwxwú7mesh (Squamish) and Səlílwətaʔ/Selilwitulh (Tsleil-Waututh) Nations.