Head of Quality

Fractional VP / Head of Quality (Cell Therapy) Overview A cell therapy biotech with phase 1 programs is seeking an experienced t Fractional VP or Head of Quality to provide immediate leadership and stabilization across Quality Assurance (QA), Quality Control (QC), and regulatory interfaces. This role is designed to address short?term operational needs while ensuring continuity, alignment, and high?quality execution within a fast?moving cell therapy environment. The ideal candidate brings deep cell therapy expertise, exceptional communication skills, and the ability to influence and guide teams constructively. This is a consultant or fractional engagement with flexibility around remote work. Key Responsibilities Provide senior?level leadership across QA, QC, and regulatory functions, ensuring integrated oversight and strategic alignment. Stabilize the quality organization by modeling clear, empathetic communication and fostering a collaborative culture. Serve as a high?

EQ partner to internal teams, offering rationale behind decisions and building alignment rather than enforcing compliance through a policing mindset. Support ongoing cell therapy development activities, bringing hands?on expertise to accelerate progress and close capability gaps. Partner with an existing external regulatory consultant to ensure cohesive regulatory strategy and execution. Identify and address operational risks, escalate issues constructively, and maintain clarity in cross?functional communication. Mentor and support mid?level quality leaders, including the Director of QA and Associate Director of QC. Provide immediate tactical support while helping shape longer?term quality and regulatory needs. Required Experience Senior?level Quality leader (VP or near?

VP caliber) with extensive cell therapy experience; NK or CAR?NK experience strongly preferred. Proven ability to step into fast?paced, resource?constrained environments and contribute immediately. Strong understanding of GxP quality systems within advanced therapy development. Demonstrated success influencing cross?functional teams without creating friction or disruption.