Quality Assurance Hybrid Jobs (NOW HIRING)

About the Company

BriaCell Therapeutics is a clinical-stage immuno-oncology company developing novel cell-based immunotherapies for solid tumors, including metastatic breast cancer. Our mission is to advance innovative immunotherapy approaches that improve outcomes for patients with difficult-to-treat malignancies.

Bria-IMTTM, BriaCell’s lead candidate, was awarded Fast Track status by FDA and is being evaluated in a pivotal Phase 3 combination study for metastatic breast cancer (MBC). MBC is breast cancer that has spread to other tissues. Bria-IMTTM is a targeted cell-based immunotherapy.

Bria-OTSTM, a platform of personalized off-the-shelf cell-based immunotherapies, is being evaluated in a Phase 1/2 clinical study initially targeting breast cancer, with extension to prostate cancer, and other cancers.

Learn more at: BriaCell | Advancing Cancer Immunotherapy Treatment

About the Position

The Senior Director, Quality Assurance will provide senior leadership across core quality systems, GxP compliance activities, and inspection readiness programs. This role is responsible for ensuring that quality systems and practices are scalable, risk-based, inspection-ready, and aligned with regulatory expectations and company priorities.

Reporting directly to the Vice President, Quality Assurance, the Senior Director will oversee broad quality functions, lead major cross-functional quality initiatives, guide quality strategy, and serve as a senior quality leader in business-critical decision-making. This position requires strong regulatory judgment, operational quality expertise, leadership presence, and the ability to influence effectively across Manufacturing, Clinical, Regulatory, R&D, vendors, CDMOs, and Executive Leadership.

Responsibilities:

• Provide senior leadership across quality operations, compliance systems, and GxP programs.
• Lead broad quality functions across multiple areas, programs, vendors, or external partners.
• Develop and execute quality strategies that support clinical development, manufacturing readiness, regulatory milestones, and organizational growth.
• Oversee quality governance, risk management, deviations, CAPAs, change control, audits, vendor oversight, documentation practices, and management review activities.
• Lead inspection readiness strategy and support regulatory inspections, partner audits, internal audits, and due diligence activities.
• Ensure quality systems are compliant, scalable, inspection-ready, and appropriate for the company’s stage of development.
• Partner with Manufacturing, Clinical, Regulatory, R&D, CDMOs, vendors, and Executive Leadership to identify and manage quality and compliance risks.
• Serve as a senior quality representative in cross-functional decision-making and strategic business discussions.
• Provide leadership during significant quality events, escalations, investigations, or remediation activities.
• Review and approve high-risk, business-critical, or regulatory-impacting quality documentation.
• Establish, monitor, and report quality metrics, trends, risks, and improvement opportunities to senior leadership.
• Drive continuous improvement, standardization, and sustainable implementation across quality systems.
• Lead, mentor, and develop quality managers and staff, strengthening team capability, accountability, and readiness for future growth.
• Promote a culture of compliance, proactive risk management, operational discipline, and continuous improvement.

Qualifications

• Bachelor’s degree in life sciences, biology, chemistry, pharmaceutical sciences, engineering, or a related scientific discipline required.
• Minimum of 12 years of progressive experience in Quality Assurance, Quality Systems, Compliance, or a related quality function within a regulated biotech, pharmaceutical, cell therapy, biologics, or clinical-stage life sciences environment.
• Minimum of 7 years of experience leading quality operations, quality systems, inspection readiness, deviations, CAPAs, change control, audits, vendor oversight, documentation practices, or quality governance.
• Minimum of 5 years of people leadership experience, including managing, coaching, and developing managers and staff.
• Strong working knowledge of applicable GxP requirements, including GMP, GCP, GLP, or related regulatory expectations as applicable to the business.
• Demonstrated experience leading inspection readiness activities and supporting regulatory inspections, partner audits, internal audits, or due diligence activities.
• Strong understanding of Quality Management Systems and the ability to translate regulatory expectations into practical, scalable business processes.
• Experience working cross-functionally with Manufacturing, Clinical, Regulatory, R&D, external vendors, CDMOs, and senior leadership.
• Demonstrated ability to lead through complexity, influence without direct authority, and make sound risk-based decisions.

Key Competencies

• Senior-level regulatory and operational quality judgment.
• Strong risk-based decision-making and issue-escalation discipline.
• Ability to lead broad functions, major systems, and enterprise-level quality initiatives.
• Strong inspection-readiness and quality governance mindset.
• Effective executive communication and ability to influence senior leaders.
• Ability to balance compliance, business priorities, timelines, quality risk, and organizational capacity.
• Strong leadership presence and credibility with internal stakeholders, vendors, partners, and auditors.
• Talent-development mindset with the ability to build leadership capability within the quality function.
• Continuous improvement orientation and ability to strengthen systems in a growing organization.
• Ability to build structure, accountability, and consistency across quality processes.

Preferred Experience

• Experience in immuno-oncology, biologics, cell therapy, oncology clinical development, or early- to mid-stage biotechnology.
• Experience with cell lines.
• Experience working with CDMOs.
• Experience supporting Phase 1-3 drug development.
• Clinical trial knowledge, including quality considerations across clinical development programs.
• Experience supporting external manufacturing, vendor qualification, supplier quality, or regulatory submissions.
• Experience building or improving processes in a growing organization.
• Experience preparing teams for regulatory inspections, partner audits, or due diligence activities.

To apply, please visit briacell.com and click on “About Us” and submit your application through the Careers section.

Equal Employment Opportunity Statement

BriaCell is an Equal Opportunity Employer. We are committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Third-Party Agency Statement

BriaCell does not accept unsolicited resumes or candidate submissions from search firms, staffing agencies, or other third-party recruiters without a signed agreement in place. Any unsolicited resumes submitted to BriaCell, its employees, or hiring managers will be considered the property of BriaCell, and no fees will be paid in the event the candidate is hired.

BriaCell Therapeutics is a clinical-stage immuno-oncology company developing novel cell-based immunotherapies for solid tumors, including metastatic breast cancer. Our mission is to advance innovative immunotherapy approaches that improve outcomes for patients with difficult-to-treat malignancies.