Associate Director, Site Quality Compliance Lead

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide. Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma. Legend Biotech is seeking an Associate Director, Site Quality Compliance Lead as part of the Quality team based in Raritan, NJ. Role Overview The Site Quality Compliance Lead (Raritan-CARVYKTI) role is an exempt level position with responsibilities for managing/driving the regulatory compliance process within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. The Site Quality Compliance Lead (Raritan-CARVYKTI) provides strategic leadership and oversight for all GxP quality compliance activities at the Raritan site. This role ensures a robust and sustainable state of compliance with global regulatory expectations, leads inspection readiness and audit management, and drives the effectiveness of key quality systems. Operating in a highly matrixed Legend–J&J environment, the role leads through influence rather than direct authority, requiring strong interpersonal, strategic, and communication capabilities. The leader models Legend’s core values—Patient First, Innovation, OneTeam, Results Driven, and Integrity—and core behaviors of Ownership & Commitment, Agility & Prioritization, Teamwork & Communication, and Continuous Improvement. This position represents the Raritan site on behalf of Legend Biotech in global forums, regulatory inspections, and cross-site/global quality initiatives. Key Responsibilities Provide strategic direction for Raritan site quality compliance programs, ensuring alignment with global regulations, Legend Quality standards, and J&J expectations. Serve as Legend business process owner for quality compliance processes, driving continuous improvement and cross-site harmonization, where necessary. Oversee compliance health monitoring, risk assessments, and performance metrics to proactively identify and mitigate risks. Maintain ownership of quality compliance–aligned Legend documents including policies, SOPs, WIs, and ensure alignment with global/regulatory requirements. Lead Quality Planning activities (Raritan-CARVYKTI-Legend) and ensure alignment with enterprise quality objectives. Manage multiple compliance-related projects with agility, prioritization, and strong organizational discipline. Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements. Understand and apply global regulations to processes to ensure compliance. Drive continuous improvement. Have advanced computer skills to increase department’s productivity, as well as broadening technical and scientific knowledge. Day-to-day management of resources, planning, and assigning work in a matrixed organization to meet goals and deadlines. Identify and manage resource needs to support growing organization and operational needs in alignment with evolving business priorities. Ability to manage multiple and complex projects, provide status reports, and coordinate with cross-functional departments. Lead…