Associate Director, Site Quality Compliance Lead

About the role

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.

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 broaden 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.
• Able 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.
• Cover 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.
• Demonstrated alignment with Legend’s core values and behaviors.