Quality Assurance Lead, Arnie Charbonneau Cancer Institute

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. 

About the University of Calgary

UCalgary is Canada's entrepreneurial university, located in Canada's most enterprising city. It is a top research university and one of the highest-ranked universities of its age. Founded in 1966, its 36,000 students experience an innovative learning environment, made rich by research, hands-on experiences and entrepreneurial thinking. It is Canada's leader in the creation of start-ups. Start something today at the University of Calgary. For more information, visit ucalgary.ca.

The University of Calgary has launched an institution-wide Indigenous Strategy committing to creating a rich, vibrant, and culturally competent campus that welcomes and supports Indigenous Peoples, encourages Indigenous community partnerships, is inclusive of Indigenous perspectives in all that we do.

As an equitable and inclusive employer, the University of Calgary recognizes that a diverse staff/faculty benefits and enriches the work, learning and research experiences of the entire campus and greater community. We are committed to removing barriers that have been historically encountered by some people in our society. We strive to recruit individuals who will further enhance our diversity and will support their academic and professional success while they are here. In particular, we encourage members of the designated groups (women, Indigenous peoples, persons with disabilities, members of visible/racialized minorities, and diverse sexual orientation and gender identities) to apply. To ensure a fair and equitable assessment, we offer accommodation at any stage during the recruitment process to applicants with disabilities. Questions regarding [diversity] EDI at UCalgary can be sent to the Office of Institutional Commitments ([email protected]) and requests for accommodations can be sent to Human Resources ([email protected]).

Do you have most but not all the qualifications? Research show that women, racialized and visible minorities, and persons with disabilities are less likely to apply for jobs unless they meet every single qualification. At UCalgary we are committed to achieving equitable, diverse, inclusive and accessible employment practices and workplaces and encourage you to apply if you believe you are right for this role. 

We encourage all qualified applicants to apply, however preference will be given to Canadian citizens and permanent residents of Canada.