Job Title

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 Canadas first nononcology Phase 1 Clinical Trials Unit at Mount St.Josephs Hospital. In this role, youll help shape a bestinclass quality and compliance framework for earlyphase 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 managers discretion upon completion of said period. Reporting to the Director, Clinical Research Administration, Providence Research and receiving guidance from the Research Operations Manager, Phase1 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 ICHGCP, 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 highquality outcomes and excellence in clinical research conduct. Responsibilities Lead and evolve the Quality Management System (QMS) design; implement and continuously improve a robust QMS that ensures Phase1 clinical trials and other regulated research activities meet ICHGCP, 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, highquality clinical trial operations. Education, Training & 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 (ASQCQA, ISO Lead Auditor), Clinical Research (ACRP, SOCRA), or Regulatory Affairs (RAC) is preferred. Skills and Abilities Strong familiarity with ICHGCP, 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 fastpaced environment. Proficiency with QMS tools, CTMS, eTMF systems, and Microsoft Office Suite. Physical ability to perform the duties of the position. Day to Day Provide strategic leadership in maintaining, monitoring, and continuously improving the QMS to ensure compliance with global regulatory standards, institutional policies, and best practices. Oversee the development, implementation, and maintenance of controlled documents including SOPs, forms, and templates, ensuring alignment with GCP guidelines and organizational requirements. Promote and embed a culture of quality across all research teams. Lead comprehensive quality risk assessments, identify potential areas of vulnerability, and implement robust mitigation strategies. Monitor evolving regulatory requirements and communicate necessary changes to research teams in a timely and actionable manner. Ensure all clinical studies adhere to ICHGCP standards and organizational QMS requirements through proactive oversight, guidance, and continuous evaluation. Design, develop, and deliver educational programs for the research community. Create and implement onboarding programs for new staff covering QMS orientation, ICHGCP principles, and ethics requirements. Organize and facilitate ongoing refresher training sessions. Provide specialized, rolespecific training for clinical operations, QA, regulatory staff, and vendors. Develop and maintain comprehensive training materials and elearning modules. Oversee training compliance for the Phase1 Clinical Trials Unit. Provide expert guidance and handson support for regulatory applications and REB submissions. Act as a liaison between research teams and ethics committees during all phases of study approval and oversight. Lead institutional efforts to achieve and maintain audit and inspection readiness. Manage postaudit activities, including tracking and reporting CAPAs, deviations, and followup measures. Conduct mock audits and inspectionreadiness drills. Lead the implementation and validation of the CTMS and other computerized systems. Oversee the maintenance and integrity of the Trial Master File (TMF/eTMF) and Investigator Site Files. Provide expert guidance and training to study teams on protocol adherence, informed consent processes, data integrity, and documentation standards. Who We Are Providence Health Care is one of the largest faithbased 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 missiondriven organization, we choose to be part of PHC because we value its longstanding 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 youll be joining. #J-18808-Ljbffr