Manager, Quality Assurance, ATMF

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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 Canadas 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 Canadas pandemic preparedness.

The Manager Quality Assurance (QA) provides strategic and operational leadership for the governance development implementation and continuous improvement of ATMFs 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 UBCs 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 worlds 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 12000 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 Facultycomprised of approximately 2200 administrative support technical/research and management and professional staff as well approximately 650 full-time academic and over 10000 clinical faculty membersis 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 xʷməθkʷəyəm (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 Childrens Hospital and BC Cancer. Flexibility to accommodate regulatory timelines and inspection activities is required.

Work Performed

Quality Systems and Compliance

• Designs establishes and governs ATMFs 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 ATMFs quality systems. Errors in judgment or failure to maintain compliance could jeopardize regulatory standing delay clinical programs compromise product quality and negatively affect ATMFs reputation and operational viability. Poor quality oversight could impact patient safety funding success and UBCs 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 ones own

- Demonstrates a commitment to enhancing ones own awareness knowledge and skills related to equity diversity and inclusion

Preferred Qualifications

• Bachelors 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.