Head of Quality

The Head of Quality will provide strategic leadership for all Quality functions at GeneFab and will report directly to the CEO. The Head of Quality will focus on developing and maintaining best-in-class Quality Control and Quality Assurance teams. The Head of Quality will be based in our Alameda, CA office and will sit on GeneFab’s senior leadership team. Responsibilities:

• Develop, implement and oversee a comprehensive quality strategy and roadmap aligned with Company goals and growth objectives
• Lead, manage and develop the Quality Control and Quality Assurance teams to deliver high performance and efficiency to meet company goals
• Senior member of the executive and site leadership team to build a culture of compliance and collaboration across the organization;
• Ensure productive quality management systems, processes, and procedures aligned with compliance and risk best practices
• Partner with cross-functional teams to ensure quality best practices and procedures are embedded in all GDMP and R&D activities
• Conduct risk assessments and audits and advise on necessary improvements and adjustments as needed
• Serve as the primary point of contact for quality-related matters for internal and external parties
  
  
  

Requirements:

• 10+ years of experience as a senior Quality Leader with extensive professional understanding of both Quality Control and Quality Assurance best practices (preferably in the CDMO / Cell Gene Therapy space)
• Deep understanding of GMP, quality systems and regulatory best practices from early-stage clinical development through commercial approval
• Extensive experience as a strategic leader with ability to lead, develop and grow teams
• Experience at a growth stage company with the ability to be both a strategic and a hands-on leader
• Strong communication skills and ability to connect with internal and external stakeholders
  
  
  

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.