Global GxP Compliance & Auditing Director

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, 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