Global GxP Compliance & Audit Leader

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

Benefits offered by this job

Medical, dental and vision insurance

401(k) retirement plan with company-m

Paid parental leave

Paid time off incl. holidays

Job summary

Legend Biotech USA Inc. seeks an Associate Director, GxP Compliance and Auditing based in Bridgewater, NJ. The role leads global GxP compliance and auditing programs, overseeing internal and external audits, inspection readiness, and supplier quality management across Somerset and Raritan facilities.

Travel 20% expected. The candidate will drive quality metrics, strategic initiatives, and regulatory intelligence, partnering with global Quality and Manufacturing teams to sustain a culture of

Qualifications

• Bachelor’s degree in a scientific or technical field required. Advanced degree preferred.
• Minimum 12 years in GxP-related Quality/Regulatory roles within biopharma. Leadership experience preferred.
• Experience conducting internal audits, hosting external audits, and supporting regulatory inspections.
• Strong knowledge of global GxP regulations (21 CFR, ICH Q10, EU GDP/GMP, Part 11).

Responsibilities

• Lead global GxP compliance and auditing programs.
• Define and maintain compliance processes, procedures, tools, and training.
• Oversee internal and external audits, inspection readiness, and quality governance.
• Develop metrics and risk-based approaches to improve quality systems.
• Partner with manufacturing, suppliers, and CROs to ensure compliance.

Skills

Quality systems

GxP

Auditing

Regulatory intelligence

Leadership

Education

Bachelor’s degree in Life Sciences/Engineering/Pharmacy

Advanced degree preferred

Tools

IT systems development lifecycle

MS Office

Job description

Legend Biotech USA Inc. seeks an Associate Director, GxP Compliance and Auditing based in Bridgewater, NJ. The role leads global GxP compliance and auditing programs, overseeing internal and external audits, inspection readiness, and supplier quality management across Somerset and Raritan facilities.

Travel 20% expected. The candidate will drive quality metrics, strategic initiatives, and regulatory intelligence, partnering with global Quality and Manufacturing teams to sustain a culture of