The Cell Facility at SickKids processes, manufactures and delivers both hematopoietic stem cell and non-hematopoietic cell products for applications in hematopoietic reconstitution (blood and marrow transplantation), immunotherapy, and regenerative medicine. The Cell Facility is imbedded within the BMT/CT Program of the Hematology/Oncology Division at SickKids and works closely with clinical and research teams to ensure the highest quality products are delivered in a timely fashion across the institution.

Here's What You'll Get To Do

The development of a quality assurance framework for the processing, manufacturing and monitoring procedures for both minimally manipulated and advanced cell products (engineered grafts, CAR-T, cytotoxic T cells) that are delivered as both clinical standard of care and on research protocols.

Reporting to Senior Manager for Quality Compliance Programs the Quality Compliance Specialist is responsible for the compliance of Cell Facility with FACT, Health Canada, Accreditation Canada, and other regulatory bodies in a GMP-compliant manner. This includes, but is not limited to:

• reviewing and ensuring compliance with Standard Operating Procedures for the Cell Facility
• review of critical events during all stages of collection, processing, manufacturing and release, validation and verification of collection and cell facility processes and the equipment
• supporting comprehensive quality review processes including cellular therapy product review (certificate of analysis), collection efficiency, patient safety and quality initiatives
• active involvement in the review of patient-specific products as required (outcome analysis, review of engraftment data, participation in REB and Health Canada applications for single patient treatments as needed)
• integration with quality management infrastructure of the program; including, but are not limited to the BMT/CT Clinical Team (both inpatient & outpatient environments), Division of Haematology/Oncology & BMT/CT, DPLM, Apheresis, Clinical Trials Support Unit, Research Institute, outside programs, and vendors
• responsibility for meeting team objectives for continuous process improvement and managing change within the team to achieve these objectives

The Quality Compliance Specialist will be expected to maintain their knowledge base in the field through networking, review of the literature, participating in academic rounds/other learning opportunities.

Here's What You'll Need

Essential Requirements

• Minimum BSc degree in a related field
• Minimum of 3 years of relevant experience
• Fundamental understanding of quality assurance in cell therapy (GLP and/or GMP)
• Experience in Quality Management Systems and Quality Standards
• Experience with Health Canada and/or similar regulatory requirements
• Excellent communication and organization skills
• Excellent time management skills and ability to manage and prioritize multiple demands
• Excellent decision making, problem recognition and problem solving skills
• Excellent negotiation and conflict resolution skills
• Effective interpersonal skills
• Ability to work effectively, independently and under stressful conditions
• Demonstrated commitment to equity, diversity and inclusion (EDI) and experience advancing EDI objectives.

Assets

• Experience working in laboratory and/or in cell processing/manufacturing preferred
• Knowledge of FACT Accreditation standards

Here's What You'll Love

Benefits

• This position is eligible for employee benefits coverage; including health and dental. The full benefits offered will be discussed at the time of position offer.
• A focus on employee wellness with our new Staff Health and Well-being Strategy. Self-care helps us support others.

Impact

• A hospital that welcomes and focuses on Equity, Diversity, and Inclusion.
• The opportunity to make an impact. Regardless of your role or professional interest, you will be making a difference at SickKids and contributing to our vision of Healthier Children. A Better World.

Employment Type

• Permanent full time: 35-hour work week.