Quality Assurance Officer, Autologous Stem Cell Therapy Program - Transfusion Medicine and Tissue Bank - Regular Full-Time 2026-18048

Position Overview

We are seeking a highly motivated and experienced individual to lead the establishment and operational launch of a new Stem Cell Laboratory. 

The successful candidate will participate in all phases of laboratory start-up, including facility planning, equipment qualification/validation, process development, writing of standard operating procedures, regulatory compliance, validation activities, documentation systems, staff onboarding, and FACT accreditation. Once the laboratory becomes operational, the individual will be responsible for maintaining quality systems, regulatory compliance, continuous improvement initiatives, and accreditation requirements.

Key Responsibilities

• Lead the planning, coordination, execution, and completion of a stem cell laboratory start-up project.
• Develop and adhere to project timelines, risk assessments and resource plans.
• Assist with laboratory design, construction, commissioning, and operational readiness activities.
• Collaborate with laboratory leadership, clinicians, researchers, facilities teams, vendors, and regulatory stakeholders.
• Participate in procurement, installation, qualification, and validation of laboratory equipment.
• Ensure laboratory processes comply with applicable regulations, standards, and accreditation requirements.
• Develop, prepare and implement:
  • Standard Operating Procedures (SOPs)
  • Document control processes in alignment with LMMD QMS
  • Validation protocols and reports
  • Training program
• Coordinate internal and external audits, inspections, and accreditation preparation activities.
• Monitor project milestones and ensure deliverables are completed on schedule and within budget.

Following successful laboratory implementation, responsibilities will include:

• Manage and maintain the laboratory Quality Management System.
• Oversee document control, change control, deviations, corrective and preventive actions (CAPA), and quality metrics.
• Manage regulatory inspections and accreditation assessments.
• Conduct internal audits and quality reviews.
• Monitor compliance with applicable standards, regulations, and institutional requirements.
• Generate daily, weekly and monthly reports as required.
• Lead continuous quality improvement initiatives.
• Investigate quality events and recommend corrective actions.
• Support validation, qualification, and ongoing quality monitoring activities.
• Provide quality training and guidance to laboratory personnel.
• Prepare quality reports for management and regulatory bodies as required.

Qualifications/Skills

• Bachelor's degree in Life Sciences, Biomedical Sciences, Biotechnology, Laboratory Medicine, Health Sciences, Nursing, Pharmacy, Engineering, or a related discipline preferred.
• CMLTO Licensed required.
• Minimum 5 years of laboratory operations, quality assurance, biotechnology, pharmaceutical, healthcare, or regulated manufacturing experience required.
• Experience with stem cell, cell therapy, tissue banking, transplant, blood banking, Health Canada Regulations, ACD, FACT, AABB, GMP, ISO required.
• Demonstrated experience managing complex, multidisciplinary projects required.
• Strong understanding of quality systems and regulated environments required.
• Excellent communication (written and oral), organizational, and stakeholder management skills required.
• Experience supporting laboratory accreditation and regulatory inspections required.
• Knowledge of risk management methodologies and quality improvement frameworks required.
• Experience developing SOPs, policies, and controlled documentation required.
• Advanced knowledge in Health and Safety Standards, WHMIS and Infection Control practices required.
• Proficiency with Microsoft Office 365 and project management software required.
• Quality certification - ASQ, CQA, CQIA or equivalent preferred.