Quality Site Head

Role: Lead Quality at CRISPR's internal manufacturing site, overseeing GMP compliance and quality assurance functions to support gene-editing therapies. Responsibilities: provide strategic and operational leadership, manage end-to-end quality processes including validation, batch review, change control, product disposition, and audit readiness; establish quality metrics; collaborate on technology transfers and lifecycle management; ensure compliance with GMP, FDA, EMA, and ICH standards; lead inspections and host regulatory audits; foster a culture of continuous improvement, transparency, and data-driven decision-making. Requirements: BS/MS in a scientific discipline; 15-20+ years in biopharma quality assurance, with direct GMP manufacturing experience; deep knowledge of regulatory guidelines and product development lifecycle; proven track record hosting health authority inspections; strong leadership and organizational skills; ability to operate strategically and hands-on. Preferred: experience in cell and gene therapy manufacturing; advanced degree (PhD) in Life Sciences; expertise in QC and analytical sciences, including method transfer and validation. HighValue: gene therapy, cell/gene modalities, GMP manufacturing, regulatory inspections, biopharma leadership, strategic quality oversight, on-site work.