Director of Quality Assurance

The Director of Quality Assurance is a key leader in fostering a culture of quality, operational excellence, and continuous improvement. This role ensures that quality and compliance are effectively embedded into daily operations and aligned with the organization’s long-term quality strategy.

The position provides strategic direction and oversight for Quality Assurance functions, driving end-to-end harmonization of quality processes, including risk management, GMP systems, and adherence to global regulatory requirements. Success in this role relies on building strong, collaborative partnerships with cross-functional stakeholders to execute strategies that support and advance the organization’s business objectives.

The ideal candidate will bring extensive experience in QA Operations, complemented by strong leadership skills and a proactive, continuous improvement mindset. Experience spanning both clinical and commercial stages is essential, along with a proven track record as a Director of QA Operations within CDMO/CMO environments, including cell therapy and viral vector programs.

This role is based on-site in Alameda, CA.

The Director of Quality Assurance is a key leader in fostering a culture of quality, operational excellence, and continuous improvement. This role ensures that quality and compliance are effectively embedded into daily operations and aligned with the organization’s long-term quality strategy.

The position provides strategic direction and oversight for Quality Assurance functions, driving end-to-end harmonization of quality processes, including risk management, GMP systems, and adherence to global regulatory requirements. Success in this role relies on building strong, collaborative partnerships with cross-functional stakeholders to execute strategies that support and advance the organization’s business objectives.

The ideal candidate will bring extensive experience in QA Operations, complemented by strong leadership skills and a proactive, continuous improvement mindset. Experience spanning both clinical and commercial stages is essential, along with a proven track record as a Director of QA Operations within CDMO/CMO environments, including cell therapy and viral vector programs.

This role is based on-site in Alameda, CA.

About GeneFab 

GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. GeneFab was formed in 2023 with a vision to combine industry leading expertise in synthetic biology with advanced cGMP capabilities in order to accelerate the development and commercialization of genetic medicines. GeneFab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production. GeneFab's technology platform includes bioinformatic-guided discovery of cell type promoters, directed evolution of small molecule-regulated gene switches, and the engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies.

We are committed to an inclusive and diverse GeneFab. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse GeneFab team. We welcome people of different backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer.