Associate Director, Global GxP Compliance & Auditing

Legend Biotech; Bridgewater (MA); Vor Ort; USD 168.000 - 221.000; Vollzeit

Benefits dieser Stelle

Medical insurance

401(k) with company match

Parental leave

Paid time off

Zusammenfassung

Legend Biotech seeks an Associate Director, GxP Compliance and Auditing, to lead global GxP programs from Bridgewater, NJ. You will oversee audits, inspection readiness, supplier quality and regulatory intelligence, while shaping quality governance across sites.

The role requires deep GxP expertise, 12+ years in quality/compliance, and 5+ years in leadership within a biotech setting. Travel 20% is anticipated, with strong cross-functional collaboration essential.

Qualifikationen

• Bachelor’s degree in a scientific/technical field; advanced degree preferred.
• Minimum 12 years of GxP experience in QA/compliance/regulatory.
• 5+ years leadership experience in a matrixed organization.
• Experience conducting internal audits and hosting external inspections.

Aufgaben

• Lead global GxP compliance and auditing programs.
• Define and maintain compliance processes, procedures, tools, and training.
• Oversee internal and external audits and inspection readiness across sites.
• Develop, implement, and improve audit strategies, metrics, and governance.
• Partner with operations and sites to foster a proactive compliance culture.

Kenntnisse

GxP compliance

Auditing

Regulatory intelligence

Quality systems

Leadership

Cross-functional collaboration

Risk-based thinking

Regulatory knowledge

Communication

Project management

Ausbildung

Bachelor’s degree in Life Sciences/Engineering/Pharmacy

Advanced degree (MS/MBA/PhD) preferred

Jobbeschreibung

Legend Biotech seeks an Associate Director, GxP Compliance and Auditing, to lead global GxP programs from Bridgewater, NJ. You will oversee audits, inspection readiness, supplier quality and regulatory intelligence, while shaping quality governance across sites.

The role requires deep GxP expertise, 12+ years in quality/compliance, and 5+ years in leadership within a biotech setting. Travel 20% is anticipated, with strong cross-functional collaboration essential.