Associate Director, GxP Compliance and Auditing

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Legend Biotech is seeking an Associate Director, GxP Compliance and Auditing as part of the Global Quality team based in Bridgewater, NJ.

Role Overview

The Associate Director, GxP Compliance and Auditing, serves as the strategic leader for the development, implementation, and continuous enhancement of Legend Biotech's global GxP compliance and auditing programs. This role oversees all core elements of the compliance framework, including internal and externa audits, inspection readiness and logistics, supplier quality management, regulatory intelligence monitoring and dissemination, Quality Management Review oversight, and quality planning activities.

Based in Bridgewater, this people-manager position oversees one direct report and is responsible for conducting internal audits at the Somerset and Raritan CARVYKTI sites, performing external third-party and supplier audits, and routinely supporting inspection readiness and related compliance activities across the Somerset and Raritan manufacturing facilities with on-site travel expected.

Key Responsibilities

* Lead and own global GxP compliance and auditing programs.

* Serve as the Global Business Process and System Owner for Compliance and Auditing.

* Define, implement, and maintain compliance processes, procedures, tools, and training for internal and external auditing, inspection readiness, Quality Management Review, emerging regulations, regulatory trends, and quality planning.

* Develop, implement, and continuously improve compliance processes and systems.

* Identify, implement, and maintain IT solutions that support compliance and auditing programs.

* Interpret and apply global regulations to ensure process and system compliance.

* Apply a risk-based approach to ensure areas of higher risk are visible across the organization.

* Identify and manage resource needs to support organizational growth and operational priorities.

* Drive quality metrics, risk-based methodologies, and continuous improvement initiatives.

* Establish audit trends, metrics, and quality system governance.

* Support and advise stakeholders on GxP compliance requirements.

* Partner with operational groups and network sites to foster a proactive compliance culture.

* Demonstrate alignment with Legend's core values and behaviors.

* Ensure compliance across the organization by sustaining a level of constant inspection readiness to meet

* regulatory requirements, guidelines and industry standards.

* Drive the Inspection Readiness Program that proactively prepares the site for Health Authority/External

* Party inspections (training, pre-audit preparation, tools, hosting, close-out etc.).

* Maintain and deploy Inspection Risk Assessment Processes and Scorecards.

* Provide PAI/PLI and audit training.

* Host/support Internal Audits and host/co-host External Health Agency Inspections (Somerset and Raritan-CARVYKTI).

* Facilitate and participate in Health Authority/External Party Inspections.

* Develop and manage the response process for Health Authority and External Partner audit observations.

* Ownership of Compliance-Aligned Quality Documents (Som Lead the Internal Audit Program for Somerset and Raritan-CARVYKTI to ensure compliance with Legend policies, procedures, and cGxP requirements.
· Generate and execute the annual internal and external audit schedules.

* Provide management with recommendations based on internal and external audit results.

* Establish and maintain cGxP compliance audit trends and metrics.

* Manage and execute external audit programs, including vendor and third-party audits.

* Oversee external audits, vendor audits, and related audit activities.

* Oversee GxP quality audits of Legend suppliers; prepare, approve, and distribute audit reports.

* Manage audit outcomes, including CAPAs and regulatory responses.

* Perform vendor risk assessments to determine and evaluate audit frequency.

* Oversee supplier qualification, approval, and risk assessment processes.

* Execute supplier qualification activities for Somerset and Raritan-CARVYKTI.

* Develop and implement audit…