Head of Quality Assurance

The role

You will establish, scale, and lead the Quality Assurance team and direct GxP compliance for bioprinted tissue therapeutics. You will embed a culture of quality across the product value chain from early development through clinical manufacturing.

What you will do

• Establish and maintain a phase-appropriate, GMP compliant Quality Management System (QMS).
• Oversee core QA functions including Document Control, Training, Change Control, Deviations, CAPA, and OOS investigations.
• Serve as Management Representative and lead inspection readiness activities.
• Host internal, vendor, and regulatory agency inspections.
• Lead Quality oversight for the GMP Cell Manufacturing facility.
• Act as primary Quality contact for regulatory agency engagement and external partner collaborations.
• Support QC functions for product characterization, release testing, and stability programs.
• Ensure data integrity, traceability, and reliability for GxP analytical and nonclinical data.
• Build and lead a high-performing QA team.
• Contribute quality expertise to regulatory submissions through authoring, review, and approval.

Required qualifications

• Bachelor’s, Master’s, or Ph.D. in Life Sciences, Biotechnology, Chemistry, Engineering, or a related scientific discipline.
• 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 (FDA, EMA, Health Canada, ICH).
• Proven track record of successfully hosting regulatory agency inspections and acting as the primary quality liaison.
• Demonstrated success in establishing, scaling, and maintaining a phase-appropriate Quality Management System (QMS) from early-stage development through clinical trials and commercial readiness.
• Direct experience authoring, reviewing, and approving Quality/CMC sections for regulatory submissions (e.g., IND, CTA, or equivalent).
• Proven ability to build a high-performing QA organization from the ground up.

Nice to have

• Advanced certifications (e.g., ASQ CQA/CQM)
• Experience in Cell/Gene Therapy, Biologics, Tissue Engineering, or Advanced Therapy Medicinal Products (ATMPs)

Benefits

• Equity
• Comprehensive benefits package
• Support for continuous learning and career progression

Before you apply

• If you don't see a job posting that matches your experience, you can submit a general application to be considered for future opportunities.

About the company

Aspect Biosystems is a biotechnology company pioneering the development of a novel category of regenerative medicine. The company uses a full-stack tissue therapeutic platform integrating AI-powered bioprinting technology, therapeutic cells, hypoimmune cell engineering, and advanced biomaterials.