Research Quality Associate

The University Health Network, where "above all else the needs of patients come first", encompasses Toronto General Hospital, Toronto Western Hospital, Princess Margaret Cancer Centre, Toronto Rehabilitation Institute and the Michener Institute of Education. The breadth of research, the complexity of the cases treated, and the magnitude of its educational enterprise has made UHN a national and international resource for patient care, research and education. With a long tradition of ground breaking firsts and a purpose of "Transforming lives and communities through excellence in care, discovery and learning", the University Health Network (UHN), Canada's largest research teaching hospital, brings together over 16,000 employees, more than 1,200 physicians, 8,000+ students, and many volunteers. UHN is a caring, creative place where amazing people are amazing the world.

Union: Non-Union
Site: Princess Margaret Cancer Centre
Department: Tumor Immunotherapy Program
Reports to: Head, Centre for Integrative Immune Analysis
Work Model: On-Site
Grade: N0:08
Hours: 37.5 hours per week
Salary: $38.17 per hour, minimum: To commensurate with experience and consistent with UHN compensation policy
Shifts: Monday - Friday
Status: Temporary Full-Time (1 year contract)
Closing Date: August 31, 2024

Position Summary
Reporting to the Head of the Centre for Integrative Immune Analysis, the Research Quality Associate (RQA) will promote a culture of quality and standards of excellence in clinical research conducted within the Princess Margaret (PM) Tumor Immunotherapy Program (TIP).

There are two centres within TIP: the Centre for Integrative Immune Analysis and the Centre for Cell Manufacturing. The RQA will be responsible for preparing documentation and implementing a new Quality Management System (QMS) for the Centre for Integrative Immune Analysis, including regulatory submissions to Accreditation Canada (Diagnostics) and Clinical Laboratory Improvement Amendments (CLIA). The RSQ will also be responsible for performing quality control (QC) and quality assurance (QA) activities for the UHN Centre for Cell Manufacturing (CCM). The CCM manufactures cell and gene therapy drug products for administration in early phase clinical trials. The RQA will provide oversight related to clinical research quality requirements and laboratory compliance as outlined by the international requirements for quality and competence standards, ISO 15189 Medical Laboratories, CLIA, and Good Manufacturing Practices (GMP), as well as local institutional policies and procedures.

The RQA supports the identification, assessment, and management of risks / quality gaps within the Centre for Integrative Immune Analysis and the Centre for Cell Manufacturing; supports the administration of new standard operating procedures (SOPs); participates in incident analysis reviews and related meetings; provides education and support to research staff around research quality; and leads or participates in the review of non-compliance issues for the purpose of providing recommendations for system learning and improvement.

Duties

Quality Management:

• Develop and implement new Quality Management System (QMS) in accordance with ISO 15189 and CLIA requirements for the Centre for Integrative Immune Analysis.
• Perform quality assurance (QA) activities (including routine, directed (for cause), and requested reviews), identifies areas of non-compliance and risk, where applicable.
• Create audit plans based on applicable internal and external standards, guidelines, policies, SOPs, and regulations.
• Plans, schedules, and conducts internal quality assurance reviews/audits of the processes, procedures, and controls employed in the design, conduct, and analysis of clinical trials.
• Plans, implements, coordinates all aspects of data assessment including document review, interviews of personnel, and direct observation of processes.
• Writes reports, including analysis and evaluation of findings, assigning grading criteria, trending, and drawing conclusions.
• Monitors processes and compliance to ensure best practices.
• Participates in identification of gaps and recommendations for system improvements.
• Leads the development, revision and implementation of SOPs and policies.
• Participates in and supports the professional growth and development of research staff through quality metrics and mentoring to achieve an overall awareness with regards to the use of program specific tools, processes, and practices to improve the conduct and quality of clinical research.
• Provides QA trending analysis and ensures appropriate follow-up has been performed.
• Reviews and follows up on corrective/preventative actions (CAPAs) for effectiveness and to verify there have been no negative consequences as a result.
• Supports benchmarking and evaluation of new QMS.
• Ensures that document control is established and maintained for SOPs and Worksheets.
• Leads or participates in projects that identify and improve research quality.

Change and Project Management:

• Coordinates and facilitates audits and regulatory inspections (e.g. AD, CLIA, Heath Canada, FACT), including but not limited to conducting pre-audit reviews, responding to auditor/inspector questions and requests, and formulating study and system level CAPAs.
• Represents the Centre for Integrative Immune Analysis and the Center for Cell Manufacturing on compliance-related projects and initiatives. Where assigned, leads such projects and initiatives, particularly those related to application of new and revised standards, guidelines, and regulations.

Risk Management:

• Participates in incident and risk management activities, including incident debrief meetings.
• Establishes processes, tools, and templates in support of risk management activities.
• Drafts risk management plan templates.
• Assists in delineating how clinical research risks will be managed, categorized, evaluated, prioritized, and escalated.

GMP-specific responsibilities:

• Reviewing the suitability of incoming materials and components, containers, closures, labeling, in-process materials, and the finished products.
• Ensuring that controls are implemented and completed satisfactorily during manufacturing operations.
• Reviewing production records and the results of quality control tests for acceptability and adherence to proper specification and limits.
• Other QC and QA activities related to GMP as required.

• At minimum, completion of a B.Sc. in Immunology, Medical/Health Sciences or equivalent from a Canadian university or an institution recognized as equivalent by a Canadian university.
• At minimum, 3 years of practical and related experience.
• Knowledge of basic laboratory terminology.
• Knowledge of laboratory safety policies and procedures.
• Knowledge of cell and gene therapy manufacturing including immune effector cells.
• Knowledge of assay methods for cell and gene therapy product testing such as flow cytometry, immunologic assays, molecular assays, and microbiological testing.
• Knowledge of regulations and guidances applicable to ISO 15189, Accreditation Canada Diagnostics, CLIA, and GMP (e.g. Health Canada, FDA, EMA, ICH)
• Knowledge and application of a quality management system, risk management system, and related quality methodology and tools, such as root cause analysis.
• Experience with best practices in QC and QA.
• Experience with FACT standards is an asset.
• Strong verbal and written communication skills, including the ability to express complex technical concepts effectively.
• Experience with data collection, monitoring, and auditing.
• Mentoring and training experience, preferred.
• Ability to work under pressure.

Why join UHN?

In addition to working alongside some of the most talented and inspiring healthcare professionals in the world, UHN offers a wide range of benefits, programs and perks. It is the comprehensiveness of these offerings that makes it a differentiating factor, allowing you to find value where it matters most to you, now and throughout your career at UHN.

• Competitive offer packages
• Government organization and a member of the Healthcare of Ontario Pension Plan (HOOPP )
• Close access to Transit and UHN shuttle service
• A flexible work environment
• Opportunities for development and promotions within a large organization
• Additional perks (multiple corporate discounts including: travel, restaurants, parking, phone plans, auto insurance discounts, on-site gyms, etc.)

Current UHN employees must have successfully completed their probationary period, have a good employee record along with satisfactory attendance in accordance with UHN's attendance management program, to be eligible for consideration.

All applications must be submitted before the posting close date.

UHN uses email to communicate with selected candidates. Please ensure you check your email regularly.

Please be advised that a Criminal Record Check may be required of the successful candidate. Should it be determined that any information provided by a candidate be misleading, inaccurate or incorrect, UHN reserves the right to discontinue with the consideration of their application.

UHN is an equal opportunity employer committed to an inclusive recruitment process and workplace. Requests for accommodation can be made at any stage of the recruitment process. Applicants need to make their requirements known.

We thank all applicants for their interest, however, only those selected for further consideration will be contacted.