Legend Biotech is seeking an Associate Director, Site Quality Compliance Lead as part of the Quality team based in Bridgewater, 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 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, EudraLex 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 listings, and discontinued/transferred product notifications.
• Ensure GMP/compliance status is maintained through strong inspection outcomes and timely CAPA closure.
• Manage Certificates of Pharmaceutical Product (CPP), Certificates of Foreign Government (CFG), and export documentation as needed.
• Conduct data compilation, reporting, and analysis to support monitoring of key performance indicators; support the preparation of compliance data for routine metrics/indicator assessment and publication, Change Review Boards, and quarterly Quality System Management Review (QSMR) presentations.
• Maintain state licenses for Raritan-CARVYKTI, including manufacturing and wholesale distributor licenses.
• Build strong partnerships across Quality, Manufacturing, MS&T, Supply Chain, and global Legend/J&J teams.
• Represent the Raritan site in global quality compliance forums and cross-site initiatives.
• Influence decision-making across matrixed organizations through strong communication, negotiation, and relationship-building.
• Lead through influence, driving alignment and shared accountability across diverse stakeholder groups.
• Drive site compliance to regulatory, enterprise, and global requirements through building positive relationships across functions, to meet unified business objectives.
• Demonstrate leadership presence and the ability to communicate effectively with multi-level stakeholders and regulatory agencies.
• Promote a proactive quality culture and continuous improvement mindset across the Raritan site.
• Provide coaching and guidance to cross-functional partners without direct supervisory authority.
• Model Legend’s core values and behaviors in all interactions.

Requirements

• Bachelor’s degree in a scientific or technical discipline required; advanced degree preferred.
• A minimum of 12 years of relevant GxP experience in Quality, Quality Compliance, Regulatory, or related functions. A minimum of 5 years of leadership experience, including senior-level project planning and cross-functional program leadership. Demonstrated success leading through influence in a matrixed organization with no direct reports. Experience hosting regulatory inspections and leading enterprise-level compliance programs. Experience in aseptic manufacturing facility, biologics, or advanced therapies strongly preferred, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.
• Deep expertise in global GxP regulations and quality compliance frameworks.
• GxP Quality System knowledge, including relevant regulations and guidances (e.g. 21 CFR parts 210, 211, 1271, 600, 601, and 610, Part 11, ICH, EU GDP/GMP, EU GMP Annex 11, EudraLex Volume 4, EU GMP Annex 1, PIC/S, MHRA, China GMP, etc.).
• Experience conducting internal audits and self-inspection, including writing audit reports, writing observations, and follow-through of observation resolution.
• Experience as host in front room/point of contact in back-room roles for audits and global agency inspections.
• Strong strategic thinking, risk-based decision making, and data driven analysis.
• Proven ability to influence across all levels of the organization.
• Ability to work independently with a high degree of accountability.
• Experience implementing global processes and driving cross site alignment.
• Knowledge of IT system development lifecycle and quality metrics management, including operational experience with electronic quality systems.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).
• Strong written and verbal communication skills; proven conflict resolution capability; effective interpersonal skills with the ability to communicate across all levels of the organization.
• Analytical problem solving, decision-making, and conflict resolution skills.
• Highly organized, agile, and able to manage shifting priorities in a fast-paced environment.
• Flexible, highly motivated, with strong organizational skills, ability to multitask with attention to detail.
• Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• Flexibility in work schedule is required.
• Demonstrated alignment with Legend’s core values and behaviors.

#Li-BZ1

#Li-Hybrid