Legend Biotech US

Associate Director, GxP Compliance and Auditing

Bridgewater, New Jersey, United States · Director

Sponsorship not specifiedDetected 1 day ago

ComplianceAuditingLogisticsCollaborationInternal AuditGxP

About the role

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.

Lead and own global GxP compliance and auditing programs.
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.
Identify and manage resource needs to support organizational growth and operational priorities.
Drive quality metrics, risk-based methodologies, and continuous improvement initiatives.
Support and advise stakeholders on GxP compliance requirements.
Partner with operational groups and network sites to foster a proactive compliance culture.
Maintain and deploy Inspection Risk Assessment Processes and Scorecards.
Establish and maintain cGxP compliance audit trends and metrics.

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.

Drive the Inspection Readiness Program that proactively prepares the site for Health Authority/External
Host/support Internal Audits and host/co-host External Health Agency Inspections (Somerset and Raritan-CARVYKTI).

This listing is sourced directly from Legend Biotech US's careers page and normalized into a canonical job model.