Associate Director, GxP Compliance and Auditing

BioSpace; Bridgewater (MA); On-site; USD 190,000 - 230,000; Full time

Job summary

Legend Biotech, based in Bridgewater, NJ, seeks an Associate Director, GxP Compliance and Auditing to lead global GxP compliance programs and audits. The role requires oversight of internal/external audits, inspection readiness, supplier quality, and regulatory monitoring across Somerset and Raritan sites with travel as needed.

The position reports to the Global Quality team and manages one direct report, driving continuous improvement and ensuring alignment with regulatory requirements and

Qualifications

• Minimum 8+ years in GxP compliance or QA within biotech or pharma.
• Experience leading internal/external audits and inspection readiness.
• Strong knowledge of cGxP regulations and regulatory trends.
• Excellent cross-functional communication and leadership skills.

Responsibilities

• Lead and own global GxP compliance and auditing programs.
• Define and maintain compliance processes, tools, and training for audits and inspections.
• Coordinate internal/external audits, inspections, and CAPA planning.
• Partner with sites to sustain inspection readiness and regulatory readiness.
• Develop audit strategies, metrics, and quality system governance.

Skills

GxP Compliance

Audit Management

Regulatory Intelligence

Quality Management

Risk Assessment

Vendor Audits

Education

Bachelor's degree in Life Sciences

Tools

eQMS / Quality Management Software

Job description

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 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 external 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 (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