About this role
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
Biotechnology company specializing in recombinant protein production and custom gene synthesis services.