GxP Compliance & Auditing Leader, Global Quality

Legend Biotech USA, Inc.; Bridgewater (MA); Vor Ort; USD 168.000 - 221.000; Vollzeit

Benefits dieser Stelle

Medical, dental, and vision insurance

401(k) with company match

Zusammenfassung

Legend Biotech is seeking an Associate Director, GxP Compliance and Auditing, based in Bridgewater, NJ. This leadership role oversees global GxP compliance, internal and external audits, and inspection readiness across Somerset and Raritan CARVYKTI sites, with on-site travel.

The role requires a strong background in GxP, regulatory intelligence, and quality systems, plus 12+ years of experience in QA/compliance and 5+ years in leadership.

Qualifikationen

• Minimum 12 years of GxP experience in QA/compliance.
• 5+ years of leadership and people management experience.
• Experience hosting regulatory inspections and internal audits.
• Strong knowledge of 21 CFR, ICH Q10, EU GDP/GMP guidelines.
• Ability to travel up to 20%.

Aufgaben

• Lead global GxP compliance and auditing programs.
• Define and maintain compliance processes, procedures, tools, and training.
• Support inspection readiness and regulatory inspections at multiple sites.
• Develop metrics and governance for quality systems and audits.
• Collaborate with manufacturing, QA, and suppliers to ensure compliance.

Kenntnisse

GxP compliance

Auditing leadership

Regulatory intelligence

Quality systems

Risk management

Cross-functional collaboration

Ausbildung

Bachelor's degree in Life Sciences or Engineering

Tools

Quality Management System (QMS)

Computerized System Validation

Jobbeschreibung

Legend Biotech is seeking an Associate Director, GxP Compliance and Auditing, based in Bridgewater, NJ. This leadership role oversees global GxP compliance, internal and external audits, and inspection readiness across Somerset and Raritan CARVYKTI sites, with on-site travel.

The role requires a strong background in GxP, regulatory intelligence, and quality systems, plus 12+ years of experience in QA/compliance and 5+ years in leadership.