Head of Quality Assurance
About the job
- A Bachelor’s, Master’s, or Ph.D. in Life Sciences, Biotechnology, Chemistry, Engineering, or a related scientific discipline.
- At least 10 years of progressive Quality Assurance leadership experience within a GMP-regulated biotech, pharmaceutical, or advanced biologics environment.
- Expert understanding and practical application of global regulatory guidelines, including FDA, EMA, Health Canada, and ICH, with a proven record of hosting regulatory agency inspections and serving as the primary quality liaison.
- Demonstrated success establishing, scaling, and maintaining a phase-appropriate Quality Management System from early-stage development through clinical trials and commercial readiness.
- Direct experience authoring, reviewing, and approving Quality/CMC sections for regulatory submissions such as IND or CTA, or equivalent.
- Proven ability to build a high-performing QA organization from the ground up, including resource planning, talent development, and fostering a collaborative quality culture.
- Establish and maintain a phase-appropriate, GMP-compliant Quality Management System across development and manufacturing activities.
- Own and oversee Document Control, Training, Change Control, Deviations, CAPA, and OOS investigations.
- Serve as the Management Representative, lead inspection readiness activities, and host internal, vendor, and regulatory agency inspections.
- Lead Quality oversight for the GMP Cell Manufacturing facility, ensuring adherence to regulatory filings and operational SOPs.
- Serve as the primary Quality contact for regulatory agency engagement and external partner collaborations.
- Support QC functions developing, validating, and executing method documentation for product characterization, release testing, and stability programs.
- Ensure data integrity, traceability, and reliability for GxP analytical and nonclinical data used in regulatory decisions.
- Build and lead the QA team, managing performance, professional development, and resource planning.
- Collaborate cross-functionally and contribute quality expertise to regulatory submissions, including authoring, reviewing, and approving relevant documentation.
- Experience in Cell/Gene Therapy, Biologics, Tissue Engineering, or Advanced Therapy Medicinal Products (ATMPs) is strongly preferred.
- Advanced certifications such as ASQ CQA/CQM are an asset.
About the company
Aspect Biosystems develops bioprinted tissue therapeutics for regenerative medicine. Its work centers on a platform that combines proprietary bioprinting technology, therapeutic cells, biomaterials, and computational design to create allogeneic tissue therapeutics for clinical use. The company works through strategic collaborations with leading pharmaceutical and biotechnology firms, funded by partnerships and investors. The product approach uses bioprinting to assemble tissue constructs layer by layer from cells and biomaterials, guided by computational design, producing off-the-shelf (allogeneic) tissue therapies. What sets the company apart is its integrated platform, a focus on allogeneic, scalable tissue products, and a collaboration-driven business model with strong industry partnerships, backed by a solid funding base. Its goal is to advance regenerative medicine by delivering a targeted pipeline of bioprinted tissue therapeutics through collaborations and continued investment.
Company Size
51-200
Company Stage
Grant
Total Funding
$352.7M
Headquarters
Vancouver, Canada
Founded
2013
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Simplify's Take
What believers are saying
- 2026-04-02: Canada added C$79 million to Aspect’s C$280 million development program.
- 2025-01-08: Aspect raised US$115 million Series B from Dimension, Novo Nordisk, and others.
- Headcount reached roughly 154 in March 2026, showing continued scale despite slower hiring.
What critics are saying
- Clinical translation from bioprinted tissues to humans remains unproven before 2031.
- Novo Nordisk’s 2026 retreat from cell therapy makes Aspect dependent on one shaky champion.
- If pancreatic implants fail in humans, Aspect’s platform loses its lead program and valuation anchor.
What makes Aspect Biosystems unique
- 2026-01-20: Aspect controls Novo Nordisk’s stem-cell islet and hypoimmune technologies.
- Aspect’s proprietary bioprinting combines cells, biomaterials, and AI design into implantable tissue.
- Canada backs Aspect’s Vancouver GMP biomanufacturing buildout, strengthening domestic manufacturing moats.
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Benefits
- Company Equity