Associate Director, GxP Compliance and Auditing

Role: Associate Director, GxP Compliance and Auditing within Legend Biotech's Global Quality team, based in Bridgewater, NJ. The primary objective is to lead and enhance the company’s global GxP compliance and audit programs, ensuring inspection readiness and regulatory adherence across manufacturing sites. Responsibilities encompass developing compliance processes, managing internal and external audits—including vendor and supplier assessments—and supporting health authority inspections at Somerset and Raritan sites. The role involves overseeing compliance systems, implementing risk-based strategies, and driving continuous quality improvements. It requires serving as the system owner for compliance frameworks, monitoring regulatory changes, and fostering a proactive compliance culture through cross-functional collaboration. The position also entails developing audit strategies, managing audit outcomes and CAPAs, and leading regulatory intelligence initiatives. Required qualifications include a bachelor’s degree in a scientific or technical field with at least 12 years of GxP-related experience, including 5 years of senior leadership within biopharma or advanced therapies, with expertise across GMP, GCP, GLP regulations. Preferred experience includes aseptic manufacturing, biologics, or cell therapies, along with familiarity with global GxP standards like 21 CFR, ICH Q10, and EU GDP/GMP. The role necessitates 20% travel, strong strategic and risk assessment skills, and excellent communication abilities. The position emphasizes building cross-site compliance frameworks and influencing at all organizational levels to maintain inspection readiness and regulatory compliance.