Global GxP Compliance & Audit Director

BioSpace; Bridgewater (MA); On-site; USD 168,000 - 221,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Eight weeks parental leave

PTO and holidays

Job summary

Legend Biotech seeks an Associate Director, GxP Compliance and Auditing to lead global GxP compliance programs across Somerset and Raritan sites. This role oversees internal audits, external audits, and inspection readiness, managing risk and regulatory trends while driving continuous improvement.

Based in Bridgewater, NJ, the position requires deep knowledge of GMP/GDP/GCP, 12+ years in quality/compliance, and strong leadership to guide cross-functional teams and ensure readiness for regulatory

Qualifications

• Bachelor’s degree in a scientific or technical field is required.
• Advanced degree (MS, MBA, PhD) is preferred.
• Minimum 12 years of GxP-related experience in QA/compliance.
• Experience leading internal and external audits and inspections.

Responsibilities

• Lead global GxP compliance and auditing programs.
• Serve as owner for Compliance and Auditing processes and systems.
• Define and maintain compliant processes, tools, and training for audits and inspection readiness.
• Manage internal/external audits and supplier audits; support Health Authority inspections.
• Develop and implement quality planning and risk-based quality governance.

Skills

GxP compliance

Auditing

Regulatory intelligence

Quality systems

Leadership

Cross-functional

Inspections

Risk assessment

Education

Bachelor’s degree in Life Sciences/Engineering

Advanced degree preferred

Tools

Quality Management System (QMS)

Microsoft Office

Job description

Legend Biotech seeks an Associate Director, GxP Compliance and Auditing to lead global GxP compliance programs across Somerset and Raritan sites. This role oversees internal audits, external audits, and inspection readiness, managing risk and regulatory trends while driving continuous improvement.

Based in Bridgewater, NJ, the position requires deep knowledge of GMP/GDP/GCP, 12+ years in quality/compliance, and strong leadership to guide cross-functional teams and ensure readiness for regulatory