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 Bridgewater, NJ
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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…