The role serves as the strategic leader for developing and enhancing Legend Biotech's global GxP compliance and auditing programs
Job Summary
The role serves as the strategic leader for developing and enhancing Legend Biotech's global GxP compliance and auditing programs.
This position is responsible for overseeing internal and external audits, inspection readiness, and supplier quality management across multiple manufacturing sites.
The incumbent will drive a proactive compliance culture by partnering with operational groups to ensure constant inspection readiness for Health Authority inspections.
Matching Summary
The role serves as the strategic leader for developing and enhancing Legend Biotech's global GxP compliance and auditing programs.
Skills & Requirements
Must-have
GxP compliance program development
Internal and external audit execution
Inspection readiness and logistics
Supplier quality management oversight
Regulatory intelligence monitoring
Risk-based compliance methodologies
Nice-to-have
Proactive compliance culture fostering
Continuous improvement initiative drive
Stakeholder advisory on requirements
Team leadership and people management
IT solution implementation for compliance
Key Requirements
Experience in biotechnology or pharmaceutical GxP compliance
Leadership experience managing compliance teams
Knowledge of FDA and international regulatory guidelines