Global QA & GxP Lead - CGT Modality

Legend Biotech USA; East Hanover (NJ); On-site; USD 176,400 - 327,600; Full time

Benefits offered by this job

Health benefits

401(k) with company match

Paid time off

Job summary

Novartis in East Hanover, NJ is seeking a Quality Assurance leader to guide development and research functions, ensuring compliance with health authorities and internal standards. The role focuses on risk analysis, quality oversight, and a culture of quality in collaboration with stakeholders.

The position requires managing QA activities across GCP, GLP, GMP domains, and supporting inspections and audits. It emphasizes proactive risk management and cross-functional partnerships to safeguard

Qualifications

• Experience leading QA programs in regulated environments.
• Strong knowledge of GCP/GLP/GMP and PV.
• Ability to manage global QA teams and drive quality initiatives.

Responsibilities

• Establish and maintain quality and data management systems across QA domains.
• Provide QA leadership to ensure quality awareness in R&D activities.
• Lead global QA organization and monitor the annual Quality Plan.
• Ensure compliance with GxP, safety and regulatory standards.
• Oversee quality risk management and inspection readiness activities.
• Lead deviation/incident governance and CAPA alignment.

Skills

Quality Assurance

GxP Experience

Audit & Inspection Management

Regulatory Affairs

Pharmacovigilance

Job description

Novartis in East Hanover, NJ is seeking a Quality Assurance leader to guide development and research functions, ensuring compliance with health authorities and internal standards. The role focuses on risk analysis, quality oversight, and a culture of quality in collaboration with stakeholders.

The position requires managing QA activities across GCP, GLP, GMP domains, and supporting inspections and audits. It emphasizes proactive risk management and cross-functional partnerships to safeguard