Summary of Duties:

Reporting to the Director of Operations, Odette Cancer Centre (OCC) and working in dyad partnership with the Stem Cell Therapy/Cellular Therapy Medical Director, the Quality Program Manager is responsible for providing program-level leadership for phase II of the Complex Malignant Hematology (CMH) Cellular Therapy Program. The role ensures continuous quality improvement, patient safety, regulatory compliance, accreditation readiness and operational excellence across the Stem Cell Transplant/Cellular Therapy continuum

The incumbent provides oversight for quality management activities including development of Standard Operating Procedures (SOPs), pathways and workflows, deviation management, internal and external audits, document control, education, quality indicators and regulatory reporting. The role ensures compliance with Health Canada CTO Regulations, FDA requirements (where applicable), FACT-JACIE accreditation standards, CIBMTR reporting requirements and Ontario Health-Cancer Care Ontario (OH-CCO) expectations.

Key responsibilities include: 

• Developing, implementing and maintaining the Stem Cell Transplant/Cellular Therapy Quality Management Plan and Total Quality Management (TQM) framework
• Leading FACT-JACIE Accreditation readiness and coordinate regulatory inspections and audits
• Overseeing SOP governance, document control, deviation management and CAPA processes
• Monitoring quality and patient safety indicators and leading continuous quality improvement initiatives
• Leading quality reviews of critical incidents, non-conformances and regulatory issues
• Ensuring accurate and timely CIBMTR and other mandatory data submissions
• Partnering with interprofessional clinical teams to translate quality findings into operational improvements
• Providing education and coaching on quality systems, accreditation standards and patient safety
• Supporting quality-related contracts, external service agreements and financial oversight associated with quality activities
• Identifying, assessing and escalating quality and regulatory risks to senior

Qualifications:

• Master’s degree in Nursing, Health Sciences, Quality Improvement or equivalent preferred
• Minimum five years’ healthcare experience with at least three years in Oncology preferred
• Demonstrated leadership in quality management within a highly regulated clinical environment
• Experience with Accreditation or other work with regulatory bodies preferred
• Experience leading audits, inspections, SOP governance and CAPA processes
• Strong project management, analytical and problem-solving skills
• Excellent communication, stakeholder engagement and interprofessional collaboration skills
• Experience developing and delivering quality education and change management initiatives
• Quality Management/Quality Improvement certification preferred