Quality Assurance Lead, Arnie Charbonneau Cancer Institute

at  The University of Calgary

Description
The Arnie Charbonneau Cancer Institute in the Cumming School of Medicine invites applications for a Quality Assurance Lead. This Full-time Fixed Term position is for approximately 1 year (based on length of grant funding), with the possibility of extension.
This position reports to the Medical Director of Biomanufacturing at the Riddell Centre.
The mission of the Riddell Centre is to reduce the burden of cancer and improve patient survival through the rapid development and implementation of safe and effective immunotherapies. The Biomanufacturing Program supports this mission by producing high-quality cell therapeutics and supportive reagents for preclinical research and clinical translation.
The QA Lead ensures the establishment and maintenance of a robust Quality Management System (QMS) and compliance with applicable quality standards and regulations. The role involves collaboration with internal and external stakeholders and requires excellent organizational and technical skills. While the position typically involves a five-day workweek, additional hours may occasionally be required to meet project deadlines or address challenges.
Summary of Key Responsibilities (job functions include but are not limited to):

Quality Assurance Management

• Develop, implement, and maintain a QMS tailored to program needs
• Manage quality events, including deviations, CAPAs, and change controls, ensuring thorough documentation and timely resolutions
• Review and approve release report testing to ensure compliance with internal quality standards and regulatory requirements
• Author and/or review protocols for equipment qualification, assay validation, and process improvements

Training & Documentation

• Train staff on quality processes and procedures to ensure consistent adherence to standards
• Maintain comprehensive training records and ensure all documentation is current and accessible

Collaboration & Compliance

• Work with Biomanufacturing Program leadership to align quality objectives with program goals
• Collaborate with internal and external partners to address quality concerns and implement best practices.
• Ensure all processes and documentation comply with GxP regulations and align with Health Canada, FDA, and ICH guidelines

Continuous Improvement

• Identify opportunities for improving quality systems and processes to enhance operational efficiency
• Monitor QA metrics and track progress toward key quality objectives
• Support the integration of new projects or technologies into the QA framework

QUALIFICATIONS / REQUIREMENTS:

• Bachelors, Masters, or PhD in a scientific, health, or related field
• 5+ years of experience in Quality Assurance in academic or industry settings, or related experience
• Experience implementing and managing QMS, including document control, deviation management, and CAPAs
• Knowledge of GxP regulations (GDP, GLP, GMP) and ICH guidelines
• Familiarity with quality event investigations, risk assessments, and root cause analysis
• Experience in writing and reviewing qualification and validation protocols
• Strong organizational and time management skills to handle complex projects and meet deadlines
• Excellent written and verbal communication skills, for efficient and comprehensive document development and effective collaboration with stakeholders
• Ability to learn and adapt quickly to new processes, techniques and evolving methodologies
• Detail and task-oriented mindset
• Ability to work respectfully and professionally within a team
• Experience in therapeutic cell or biological product manufacturing is an asset
  Application Deadline: February 7, 2025
  We would like to thank all applicants in advance for submitting their resumes. Please note, only those candidates chosen to continue on through the selection process will be contacted.
  This position is part of the AUPE bargaining unit, and falls under the Specialist/Advisor Job Family, Phase 3.
  For a listing of all management and staff opportunities at the University of Calgary, view our Management and Staff Careers website.

Please refer the Job description for details