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 Bridgewater New Jersey we are advancing the next generation of cell therapy through a portfolio of innovative technologies including autologous allogeneic and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T) T-cell receptor (TCR-T) natural killer (NK) cell-based therapies and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites we are committed to discovering and developing safe effective and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with 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 developmentimplementation and continuous enhancement of Legend Biotechs global GxP compliance and auditingprograms. This role oversees all core elements of the compliance framework including internal and externaaudits inspection readiness and logistics supplier quality management regulatory intelligence monitoring anddissemination Quality Management Review oversight and quality planning activities. Based in Bridgewater thispeople-manager position oversees one direct report and is responsible for conducting internal audits at theSomerset and Raritan CARVYKTI sites performing external third-party and supplier audits and routinelysupporting inspection readiness and related compliance activities across the Somerset and Raritan manufacturingfacilities 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 andexternal auditing inspection readiness Quality Management Review emerging regulations regulatorytrends 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 Legends 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 andRaritan-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 (SomLead 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 strategies and plans (e.g. Qualification of Apheresis Centers)
• Annual Environmental Social Governance Reporting Stewardship.
• Lead regulatory intelligence activities and monitor emerging regulations; oversee the cross-functional Regulatory Intelligence Program to identify applicable regulatory changes and establish implementation timelines and actions for Legend.
• Execute the GxP Regulatory Intelligence Program including impact assessments maintenance routine dissemination to stakeholders publication and intranet site maintenance for Somerset and Raritan-CARVYKTI.
• Oversee and execute the Quality Systems Management Review Program (QSMR) working cross functionally to identify key quality metrics that monitor product quality quality systems compliance sustainability and drive continuous improvement and actions.
• Drive/coordinate Quality Planning.
• Build cross-functional partnerships to strengthen compliance culture.
• Provide QA advice to stakeholders (e.g. manufacturing CROs CMOs) based on analyses and interpretation of cGxP regulations.
• Establish key stakeholder relationships with Global and Site Quality functions Manufacturing operations and Suppliers.
• Ability to interact and influence all levels within the organization to achieve compliance.
• Maintain cGxP related quality system SOPs in compliance with all applicable regulatory requirements to align with existing company policies.
• Ownership of Compliance-Aligned Quality Documents at Bridgewater and Somerset.
• Support Annual Environmental Social Governance Reporting activities.

Requirements

• Bachelors degree in a scientific or technical discipline required (e.g. Life Sciences Engineering Pharmacy or related scientific/technical discipline). Advanced degree (MS MBA PhD) preferred.
• Minimum 12 years of relevant GxP work experience in Quality Quality Compliance Regulatory or related functions within the biopharmaceutical or advanced therapies industry. Minimum 5 years of leadership experience including senior-level project planning and execution. Demonstrated success leading through influence in a matrixed organization; experience managing direct reports is beneficial but not required for this role. Proven experience conducting internal audits hosting external audits and supporting global health authority inspections. Experience implementing global processes and driving cross-site alignment. Experience hosting regulatory inspections and leading enterprise-level compliance programs. Experience in aseptic manufacturing facility biologics or advancetherapies strongly preferred preferably in quality assurance manufacturing compliance clinical quality or cell therapy. Experience working across all GxP functions (GMP GDP GCP GLP) preferred.
• 20% travel is required.
• Knowledge of GxP requirements for quality systems and processes that enable compliance.
• Deep expertise in global GxP regulations and quality compliance frameworks including: o 21 CFR ICH Q10 EU GDP/GMP Part 11/Annex 11 PIC/S MHRA China GMP Regulations.
• Experience conducting internal audits and self-inspections including writing audit reports issuing observations and ensuring follow-through to closure.
• Experience in Regulatory Intelligence mining.
• Experience hosting front-room/back-room activities for external audits and global agency inspections.
• Ability to interpret evolving regulations and apply them to processes systems and quality governance.
• Strong strategic thinking risk-based decision-making and data-driven analysis.
• Proven experience implementing global processes and driving cross-site harmonization.
• Ability to anticipate compliance risks and proactively strengthen systems and controls.
• Demonstrated ability to lead complex programs and quality initiatives across multiple sites.
• Ability to provide clear direction and influence individuals across all levels of the organization.
• Proven ability to influence across all levels of the organization without direct authority.
• Strong written and verbal communication skills.
• Effective interpersonal skills with the ability to collaborate across functions and geographies.
• Proven analytical problem-solving and conflict-resolution skills.
• Ability to work independently with a high degree of accountability and sound judgment.
• IT system development lifecycle knowledge (requirements gathering change management testing implementation continuous improvement).
• Experience defining key quality metrics reporting metrics analyzing trends and applying process improvement techniques.
• Operational experience with electronic quality systems and digital compliance tools.
• Proficiency with Microsoft Office applications (Outlook Excel Word PowerPoint).
• Highly organized agile and able to manage shifting priorities in a fast-paced dynamic environment.
• Flexible highly motivated with strong organizational skills and the ability to multitask with attention to detail.
• Must be able to manage critical deadlines and competing priorities effectively.
• Effective time-management skills and ability to drive results independently.
• Demonstrated alignment with Legends core values: Patient First Innovation OneTeam Results Driven Integrity.
• Demonstrated alignment with Legends core behaviors: Ownership & Commitment Agility & Prioritization Teamwork & Communication Continuous Improvement.

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Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

Work Authorization & Employment Eligibility

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations we participate in the E-Verify program. If you are selected for employment you will be required to complete the Form I-9 process and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair transparent and welcoming hiring experience for all candidates.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race color creed religion national origin ancestry citizenship status age sex or gender (including pregnancy childbirth related medical conditions and lactation) gender identity or gender expression (including transgender status) sexual orientation marital status military service and veteran status disability genetic information or any other protected characteristic under applicable federal state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.