Head of Quality Assurance

Job description

We are seeking a Head of Quality Assurance to join Aspect’s technical operations team. Reporting to the Chief Technical Operations Officer, you will be directly responsible for establishing, scaling, and leading the Quality Assurance (QA) team and directing overall GxP compliance for our bioprinted tissue therapeutics. You will be accountable for embedding a culture of quality, integrity, and compliance across the entire product value chain, from early development through clinical manufacturing. **Responsibilities** - Establish and maintain a phase-appropriate, GMP compliant Quality Management System (QMS) across all development and manufacturing activities. - Own and oversee core QA functions, including Document Control, Training, Change Control, Deviations, CAPA, and OOS investigations. - Serve as the Management Representative and lead all inspection readiness activities and host internal, vendor, and regulatory agency inspections (FDA, EMA, Health Canada). - Lead Quality oversight for the GMP Cell Manufacturing facility, ensuring adherence to regulatory filings and operational SOPs. - Primary Quality contact for regulatory agency engagement and external partner collaborations. - Provide support to the QC functions responsible for developing, validating, and executing method documentation for product characterization, release testing, and stability programs. - Ensure data integrity, traceability, and reliability for all GxP analytical and nonclinical data used in regulatory decisions. - Build and lead a high-performing QA team, managing performance, professional development, and resource planning. - Collaborate cross-functionally and contribute quality expertise to all regulatory submissions (IND, CTA) through authoring, review, and approval of relevant documentation. **Qualifications & Experience** - **Education:** Bachelor’s, Master’s, or Ph.D. in Life Sciences, Biotechnology, Chemistry, Engineering, or a related scientific discipline. Advanced certifications (e.g., ASQ CQA/CQM) are an asset. - **Biotech Industry Tenure:** 10+ years of progressive Quality Assurance leadership experience within a GMP-regulated biotech, pharmaceutical, or advanced biologics environment. - **Modality Expertise:** Strong preference for experience in Cell/Gene Therapy, Biologics, Tissue Engineering, or Advanced Therapy Medicinal Products (ATMPs). - **Regulatory Compliance & Inspections:** Expert understanding and practical application of global regulatory guidelines (FDA, EMA, Health Canada, ICH). Proven track record of successfully hosting regulatory agency inspections and acting as the primary quality liaison. - **Phase-Appropriate QMS Design**: Demonstrated success in establishing, scaling, and maintaining a phase-appropriate Quality Management System (QMS) from early-stage development through clinical trials and commercial readiness. - **Submissions Experience:** Direct experience authoring, reviewing, and approving Quality/CMC sections for regulatory submissions (e.g., IND, CTA, or equivalent). - **Team Builder & Mentor:** Proven ability to build a high-performing QA organization from the ground up, with a focus on resource planning, talent development, and embedding a collaborative culture of quality. The hiring range for this role is $191,000 - $202,000, annually. Our ranges are based on market data. Offered salaries will be based on a combination of factors including, but not limited to, job-related knowledge, skills, education, and experience. For candidates who exceed role requirements, we are open to exploring above-range offers. Note that base salary is just one part of the overall compensation at Aspect. Members of the Aspect team also receive equity, a comprehensive benefits package, and support for continuous learning and career progression. **Who We Are** Aspect Biosystems is a biotechnology company pioneering the development of a novel category of regenerative medicine designed to restore or supplement biological function and deliver curative therapies for some of the most elusive diseases. Aspect is developing these bioengineered cellular medicines by applying its full-stack tissue therapeutic platform, which integrates proprietary AI-powered bioprinting technology, therapeutic cells, hypoimmune cell engineering, and advanced biomaterials. Aspect is advancing its therapeutic pipeline across multiple endocrine and metabolic diseases, including diabetes and rare endocrine disorders. If you are committed to making a real impact and accelerating the development of life-changing therapies, we want to hear from you! Curious about our current perks and benefits? Learn more [here](https://aspectbiosystems.com/careers). At Aspect Biosystems, our strength has always been in our diversity. Different people, thinking differently, unified in creating a world that is better for us all. We are committed to creating an inclusive environment for everyone on our team. All aspects of employment — including the decision to hire, promote, discipline, or terminate — are based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, citizenship status, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, political affiliation, or any other status protected under federal, state, provincial, or local law. If you're interested in joining our team but don't see a job posting that matches your experience or background, we encourage you to [submit a general application](https://boards.greenhouse.io/aspectbiosystems/jobs/4009049008) to be considered for future opportunities!