Associate Director, Site Quality Compliance Lead

Legend Biotech is seeking an Associate Director, Site Quality Compliance Lead as part of the Quality team based in Raritan, NJ.

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, One Team, 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.

• 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 Raritan site quality compliance and regulatory processes in a GMP manufacturing environment.
• Host regulatory inspections and independent audits, ensuring strong front-room/back-room coordination.
• Develop and maintain a turn-key inspection management program and align with other Legend sites, as necessary.
• Oversee audit/inspection programs, audit/inspection readiness activities, and audit/inspection response management.
• Coordinate front room/ back-room activities for health authority inspections and independent audits.
• Ensure and maintain a state of inspection readiness.
• Perform compliance walkthroughs as part of audit/inspection readiness activities to ensure that the site is an inspection ready state.
• Establish a routine cadence of lessons learned, audit/inspection/industry insights, and inspection readiness program status reviews.
• Ensure timely and effective closure of CAPAs, change controls, and audit/inspection commitments.
• Drive regulatory compliance through cross-functional collaboration and strong communication.
• Ensure compliance with global regulations (e.g. 21 CFR parts 210, 211, 1271, 600, 601, and 610, Part 11, ICH, EU GDP/GMP, EU GMP Annex 11, Eudra Lex Volume 4, EU GMP Annex 1, PIC/S, MHRA, China GMP, etc.).
• Drive integration and optimization with J&J partners.
• Maintain the Raritan Site Master File (SMF) and ensure accuracy and regulatory alignment.
• Oversee the internal audit, self-inspection, and GEMBA walk programs, ensuring timely implementation, execution, and improvement of the programs.
• Support quality systems activities including annual product review, site risk register, and internal quality agreements.
• Support the creation, assessment and closure, as needed, of corrective actions, change controls, or audit/inspection actions related to the site/product.
• Oversee CAPA, change control, APR/APQR, and quality monitoring program effectiveness.
• Maintain centralized tracking of regulatory registrations, certifications, and compliance records.
• Ensure timely annual registration renewals and accurate facility metadata.
• Maintain FEI product listings, NDC…