Head of Quality Assurance

Aspect Biosystems•Fremont, CA

About The Position

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.

Requirements

Education: 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.
Strong preference for experience in Cell/Gene Therapy, Biologics, Tissue Engineering, or Advanced Therapy Medicinal Products (ATMPs).
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, with a focus on resource planning, talent development, and embedding a collaborative culture of quality.

Nice To Haves

Advanced certifications (e.g., ASQ CQA/CQM) are an asset.

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.