Quality Systems Leader for CAR-T Manufacturing

Legend Biotech; Raritan (NJ); On-site; USD 146,000 - 192,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid parental leave

Paid time off

Job summary

Legend Biotech is seeking an Associate Director, Quality Systems in Raritan, NJ to lead quality systems oversight for a cell therapy manufacturing site. You will manage investigations, CAPA, change control, and site quality metrics to support commercial requirements in a sterile GMP environment.

The role requires a minimum of 10 years in quality within a cGMP facility and a Bachelor’s degree in a related science/engineering field; an advanced degree is preferred.

Qualifications

• Bachelor's degree required; advanced degree preferred.
• Minimum 10 years of Quality experience in a cGMP-regulated facility or related biotech environment.
• Demonstrated experience leading quality systems, complex investigations, CAPA programs, governance, and regulatory readiness.

Responsibilities

• Oversee Quality Systems, Systems Support, and Investigations teams to meet goals and deadlines.
• Lead risk-based quality improvements, governance programs, and site quality metrics.
• Support regulatory inspections and audits; ensure inspection readiness and robust CAPA process.
• Collaborate with Manufacturing, Quality Control, Engineering, Supply Chain, and Technical Operations to harmonize procedures and drive risk-based decisions.

Skills

Quality systems oversight

Investigations & CAPA

Change control

Regulatory inspections readiness

Cross-functional leadership

Risk management

Project management

Data analysis

Education

Bachelor’s degree in Science, Engineering, Biotechnology, Pharmacy, Information Science, Biology, or related technical discipline

Advanced degree preferred

Job description

Legend Biotech is seeking an Associate Director, Quality Systems in Raritan, NJ to lead quality systems oversight for a cell therapy manufacturing site. You will manage investigations, CAPA, change control, and site quality metrics to support commercial requirements in a sterile GMP environment.

The role requires a minimum of 10 years in quality within a cGMP facility and a Bachelor’s degree in a related science/engineering field; an advanced degree is preferred.