Quality Assurance Lead, Arnie Charbonneau Cancer Institute at the University of Calgary

Jan 28, 2025

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(equity@ucalgary.ca) and requests for accommodations can be sent to Human Resources (hrhire@ucalgary.ca).

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.

Knowledge Mobilization & Research Impact Specialist

Feb 14, 2024

About Western

With an international reputation for success, Western ranks as one of Canada’s top research-intensive universities. Our research excellence expands knowledge and drives discovery with real-world application. Western also provides an exceptional employment experience, offering competitive salaries, a wide range of employment opportunities and one of Canada’s most beautiful campuses.

About Us

Western ranks as one of Canada’s top research-intensive universities. With contributions that range from fundamental research to applied discovery, its researchers advance knowledge and provide tangible benefits for the economic, social, health and cultural development of citizens in London, in Canada, and around the world. Western Research provides strategic and comprehensive support to foster a culture of research excellence that enhances Western University’s profile on the global stage.

Responsibilities

The Knowledge Mobilization & Research Impact Specialist’s primary mandate is to maximize Western’s research impact by building capacity, connections, and a community that prioritizes excellence in discovery with innovation in research mobilization and dissemination. The role will support strategic initiatives to build a framework and culture of inclusive research assessment that better profile the breadth of research and research impact at Western. The Specialist will identify and develop strategic relationships locally, nationally facilitate the removal of barriers to research knowledge by training, empowering and supporting Western faculty, staff and students on the implementation of strategic plans for mobilizing research outcomes and supporting research partnerships. The role will assist directly with knowledge user and partner identification and engagement, funding opportunity dissemination and support, research proposal development, implementation of internal initiatives and programming, and the curation of resources to support innovative mobilization, research co-creation, and research impact. The overarching purpose of the role is to enhance Western’s research success and funding performance.

Qualifications

Education:

• 4 year undergraduate thesis-based degree
• Certificate in knowledge translation/mobilization
• Graduate degree in a research-based discipline preferred
• Courses in quantitative and qualitative analysis preferred

Experience:

• 5 years’ experience supporting knowledge mobilization and research assessment practices within a post-secondary environment
• 1 year experience supporting grant proposals
• Proven experience writing successful proposals and working with major government research programs is preferred
• Experience preparing presentations, workshops, toolkits and/or resources related to knowledge mobilization and research impact assessment is preferred
• Knowledge of open access, open science, inclusive and responsible research assessment practices, bibliometrics preferred
• Certificate and/or completed training related to cultural safety preferred

Knowledge, Skills & Abilities:

• In-depth knowledge of best practices for knowledge mobilization and inclusive research assessment
• In-depth knowledge of Canadian peer-review granting systems, funding landscape and knowledge mobilization requirements 
• Demonstrated ability to develop and deliver educational sessions and resources to diverse stakeholders to increase their awareness of, and capacity for, knowledge mobilization, research dissemination, partnered research and research impact assessment
• Persuasive oral and written communication skills, plain language skills and critical thinking skills to translate information into easily understood terms, summarize information, and provide a rationale for action
• Passion for supporting and elevating research Proficiency in program management and mixed-methods evaluation
• Experience in event planning and coordination
• Advanced computer skills in Microsoft Office Suite
• Ability to research new avenues of funding from federal granting agencies, industry and other funding sources
• Strong editing and proofreading abilities with attention to detail with emphasis on requirements for proposal development, reports and presentations
• Superior time management and organizational skills to create and maintain required processes and meet deliverables
• Influential interpersonal skills to interface with stakeholders, build relationships and network
• Ability to analyze and synthesize sizable amounts of detail/data with an ability to communicate information to academic and non-academic audiences using different approaches
• Ability to work collaboratively with diverse stakeholders to inform work goals, advance work independently, and share openly
• A well-defined sense of diplomacy, solid negotiation and facilitation skills
• Proven ability to work well with diverse groups at all levels within the institution and external parties, exercising appropriate judgment in decision making
• A desire to grow and advance skills, which is demonstrated by attending conferences, workshops and other professional developmental opportunities to enhance performance

Western Values Diversity

The University invites applications from all qualified individuals. Western is committed to employment equity and diversity in the workplace and welcomes applications from women, members of racialized groups/visible minorities, Indigenous persons, persons with disabilities, persons of any sexual orientation, and persons of any gender identity or gender expression.

Accommodations are available for applicants with disabilities throughout the recruitment process. If you require accommodations for interviews or other meetings, please contact Human Resources at hrhelp@uwo.ca or phone 519-661-2194.