City : Vancouver

Category : Full time

Industry : Educational Services

Employer : University of British Columbia

Staff - Non Union

Job Category

M&P - AAPS

Job Profile

AAPS Salaried - Research and Facilitation, Level C

Job Title

Manager, Quality Assurance, ATMF

Department

ATMF | Office of Research | Faculty of Medicine

Compensation Range

$7,622.83 - $11,886.67 CAD Monthly

The Compensation Range is the span between the minimum and maximum base salary for a position. The midpoint of the range is approximately halfway between the minimum and the maximum and represents an employee that possesses full job knowledge, qualifications and experience for the position. In the normal course, employees will be hired, transferred or promoted between the minimum and midpoint of the salary range for a job.

Posting End Date

April 7, 2026

Note: Applications will be accepted until 11:59 PM on the Posting End Date.

This position is subject to the satisfactory completion of required background checks

Job End Date

December 31, 2028

 

 

At UBC, we believe that attracting and sustaining a diverse workforce is key to the successful pursuit of excellence in research, innovation, and learning for all faculty, staff and students. Our commitment to employment equity helps achieve inclusion and fairness, brings rich diversity to UBC as a workplace, and creates the necessary conditions for a rewarding career. 

Job Summary
The Advanced Therapeutics Manufacturing Facility (ATMF) is a new CFI-funded project and a flagship initiative of Canada’s Immuno-Engineering and Biomanufacturing Hub (CIEBH), a UBC-led national research hub that aligns immune-engineering expertise with biomanufacturing and public health strengths in British Columbia. ATMF is also a key deliverable of the BC MS Cell Therapies Translational Research Network, with the goal of accelerating novel cell and nucleic acid-based therapies for neurological and autoimmune diseases. This multi-year, multi-phase initiative aims to establish a Good Manufacturing Practice (GMP) biomanufacturing core facility to support early-phase clinical trials, address current health challenges, and strengthen Canada’s pandemic preparedness.

The Manager, Quality Assurance (QA) provides strategic and operational leadership for the governance, development, implementation, and continuous improvement of ATMF’s Quality Management System (QMS), ensuring GMP compliance and inspection readiness across the establishment of the ATMF.  This role is responsible for ensuring compliance with applicable regulatory requirements and quality standards governing the manufacture of advanced therapeutic products.

The Manager, QA works closely with ATMF leadership, senior university administration, regulatory authorities, and internal and external stakeholders to ensure that ATMF operations meet Canadian and international GMP expectations and are inspection-ready throughout the facility lifecycle.

Organizational Status
The University of British Columbia is a global centre for research and teaching, consistently ranked among the top 20 public universities in the world. Since 1915, UBC’s entrepreneurial spirit has embraced innovation and challenged the status quo. UBC encourages its students, staff and faculty to challenge convention, lead discovery and explore new ways of learning. At UBC, bold thinking is given a place to develop into ideas that can change the world.

Our Vision: To Transform Health for Everyone

Ranked among the world’s top medical schools with the fifth-largest MD enrollment in North America, the UBC Faculty of Medicine is a leader in both the science and the practice of medicine. Across British Columbia, more than 12,000 faculty and staff are training the next generation of doctors and health care professionals, making remarkable discoveries, and helping to create the pathways to better health for our communities at home and around the world.

 

The Faculty—comprised of approximately 2,200 administrative support, technical/research and management and professional staff, as well approximately 650 full-time academic and over 10,000 clinical faculty members—is composed of 19 academic basic science and/or clinical departments, 3 schools, and 25 research centres and institutes. Together with its University and Health Authority partners, the Faculty delivers innovative programs and conducts research in the areas of health and life sciences. Faculty, staff and trainees are located at university campuses, clinical academic campuses in hospital settings and other regionally based centres across the province.

 

The UBC Vancouver Campus is located on the traditional, ancestral, and unceded territory of the xʷməθkʷəy̓əm (Musqueam) people. The City of Vancouver is located on Musqueam, Squamish, and Tsleil-Waututh First Nations territory.

The Quality Assurance (QA) Manager receives direct oversight and strategic direction from the ATMF Head of Operations, who in turn reports to the ATMF Project Lead. The QA Manager is responsible for leading the Quality Unit and supervising staff in the governance of the Quality Management System (QMS), ensuring all departmental objectives are strictly aligned with the operational mandates set by the ATMF Head of Operations.

The QA Manager works closely with the Quality Control (QC), Production, and Process Development (PD) managers to ensure that all facility activities meet the highest levels of GMP compliance and regulatory expectations.

Working Conditions

The position is based at the ATMF on the UBC Vancouver Campus. Travel may be required between affiliated laboratory and clinical sites, including BC Children’s Hospital and BC Cancer. Flexibility to accommodate regulatory timelines and inspection activities is required.

Work Performed

Quality Systems and Compliance

• Designs, establishes, and governs ATMF’s Quality Management System in alignment with applicable GMP regulations and standards for advanced therapeutic products; ensures QA systems are audit-ready and capable of supporting clinical-grade manufacturing across the facility

• Develops and maintains a multi-year QA program roadmap, aligned to the establishment of the ATMF (e.g. planning, implementation and early operations)

• Accountable for QA signatory for GMP documentation and quality decisions; Authorizes and maintains quality policies, procedures, and standard operating procedures (SOPs) governing GMP manufacturing, quality control, document control, deviation management, corrective and preventative actions (CAPA), change control, risk management, and supplier qualification.

• Establishes QA program governance, including workplans, risk registers, decision-logs and reporting measures to support regulatory readiness.

• Exercises independent authority over quality oversight of manufacturing, testing, and support activities to confirm product quality, safety, and data integrity; has authority to halt activities where compliance, data integrity, or safety is at risk.

• Leads quality risk management activities to proactively identify, assess, mitigate, and monitor risks associated with ATMF operations and products.

Regulatory Affairs and Inspection Readiness

• Acts as the primary QA liaison with regulatory authorities and accreditation bodies, including Health Canada, for inspections, audits, and regulatory submissions.

• Provides quality oversight and review for regulatory filings, including clinical trial applications, amendments, and supporting quality documentation.

• Leads preparation for, participation in, and follow-up of internal audits, external audits, and regulatory inspections.

• Ensures timely and effective responses to audit observations, inspection findings, and regulatory commitments.

Operational Quality Oversight

• Provides QA oversight of technology transfer activities from process development to GMP manufacturing environments.

• Reviews and approves batch records, quality records, validation documentation, and controlled documents prior to GMP use.

• Authorizes qualification and validation activities for facilities, utilities, equipment, computerized systems, and processes, in collaboration with technical teams.

• Ensures appropriate quality oversight of material management, including receipt, sampling, testing, release, and supplier performance.

Collaboration and Strategic Partnerships

• Works closely with and provides QA leadership to embed quality by design principles across ATMF operations;

• Engages with UBC faculty, clinical partners, and external collaborators to ensure compliant research translation and manufacturing activities meet GMP and regulatory requirements

• Contributes quality expertise to funding proposals (including drafting sections of funding applications), institutional planning, and strategic initiatives supporting ATMF growth and sustainability.

Supervision, Training, and Culture

• Recruits, trains, and manages QA staff supporting ATMF operations.

• Develops and delivers GMP and quality training programs for ATMF personnel.

• Fosters a culture of quality, compliance, accountability, and continuous improvement across the facility.

• Promotes an inclusive, respectful, and collaborative working environment aligned with UBC values.

Project Management and Reporting

• Leads QA program planning and execution; develops and manages QA-related project plans, timelines, and deliverables.

• Prepares quality reports, metrics, and presentations to inform executive decision-making for ATMF leadership, UBC administration, funding agencies, and regulatory stakeholders.

• Acts on behalf of ATMF as delegated by the Head, Operations, and provides direct support as required.

Consequence of Error/Judgement
The incumbent is expected to exercise a high degree of professional judgment and independence in managing ATMF’s quality systems. Errors in judgment or failure to maintain compliance could jeopardize regulatory standing, delay clinical programs, compromise product quality, and negatively affect ATMF’s reputation and operational viability. Poor quality oversight could impact patient safety, funding success, and UBC’s standing as a leader in advanced biomanufacturing.

Supervision Received
This position operates with wide latitude under the general supervision of the Head, Operations. Performance is reviewed periodically based on achievement of objectives, regulatory readiness, and quality outcomes.

Supervision Given
Provides leadership, functional direction, and technical QA expertise to quality staff and cross-functional teams. Oversees day-to-day QA operations and personnel.

Minimum Qualifications
For research work, a post-graduate degree or equivalent professional designation with a minimum of four years of related experience, or an equivalent combination of education and experience. Otherwise, an undergraduate degree in a relevant discipline is required with a minimum of six years of related experience, or an equivalent combination of education and experience.

- Willingness to respect diverse perspectives, including perspectives in conflict with one’s own

- Demonstrates a commitment to enhancing one’s own awareness, knowledge, and skills related to equity, diversity, and inclusion

Preferred Qualifications

• Bachelor’s degree in life sciences with approx. 6 years of Quality Assurance experience, or comparable background of relevant QA experience in drug development in the bio-tech or pharmaceutical industry.

• Strong knowledge of Canadian and international regulatory frameworks, including Health Canada, FDA, and EMA expectations.

• Experience establishing or scaling quality systems for early-phase clinical manufacturing facilities

• Extensive experience working within GMP-regulated environments for biologics, cell and gene therapies, and/or nucleic acid-based products.

• Good understanding of the drug development process, including performance process qualification and the interdependencies between QA and other functional areas. Previous experience with drug substance or drug product manufacturing is highly desirable.

• Demonstrated experience leading audits, inspections, and regulatory interactions.

• Strong organizational, analytical, and problem-solving skills, with excellent written and verbal communication abilities.

• Proven leadership experience supervising QA or compliance personnel.

• Experience maintaining an electronic quality management system is beneficial.

• Ability to work flexibly, including occasional evenings or weekends, to support operational and regulatory requirements.