Quality Compliance Lead – GMP & Audit Readiness

Legend Biotech USA; Morris Plains (NJ); On-site; USD 114,000 - 212,000; Full time

Benefits offered by this job

Performance-based incentive

Equity awards

Health, life and disability benefits

401(k) with company match

Generous time off

Job summary

Novartis in Morris Plains, NJ, seeks a Quality Team Leader QA Compliance to lead a fast-moving team ensuring robust quality systems and patient safety. You will guide QA activities, support regulatory inspections, and drive continuous compliance improvements across the site.

You will oversee reviews, CAPA, change controls, and data integrity, ensuring adherence to cGMP and GxP standards while partnering across functions.

Qualifications

• Must have 5+ years in Quality Assurance or Quality Control in pharmaceutical manufacturing.
• Proven ability to lead teams in a regulated quality organization.
• Strong knowledge of cGMP and GxP requirements.
• Experience supporting audits, inspections, change controls, CAPA and quality systems.
• Ability to manage compliance risks and analyze quality metrics.

Responsibilities

• Lead day-to-day operations within the QA Compliance function and develop a high-performing quality team.
• Oversee Product Quality Review and Annual Product Quality Review planning, execution, and compliance activities.
• Support qualification and validation programs through planning, guidance, and quality review activities.
• Drive implementation and continuous improvement of quality systems, including documentation management processes.
• Coordinate corrective and preventive action activities and ensure timely follow-up on quality commitments.
• Lead audit and inspection readiness efforts, including support during regulatory and internal inspections.
• Review change controls, monitor compliance metrics, and ensure adherence to regulatory and data integrity requirements.

Skills

Quality Assurance

Team Leadership

Regulatory Compliance

GxP Knowledge

Audits & Inspections

Education

Bachelor's degree in Chemistry, Pharmacy, Biology, Biochemistry, or another scientific discipline

Job description

Novartis in Morris Plains, NJ, seeks a Quality Team Leader QA Compliance to lead a fast-moving team ensuring robust quality systems and patient safety. You will guide QA activities, support regulatory inspections, and drive continuous compliance improvements across the site.

You will oversee reviews, CAPA, change controls, and data integrity, ensuring adherence to cGMP and GxP standards while partnering across functions.