Senior Quality Systems Leader - Cell Therapy

BioSpace; 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

Eight weeks parental leave

Job summary

Legend Biotech USA Inc. in Raritan, New Jersey, is seeking an Associate Director, Quality Systems to lead the Quality Systems function for a CAR-T manufacturing site.

The role drives investigations, CAPAs, change control, and site quality metrics to ensure regulatory compliance in a sterile GMP environment. The candidate will manage a team of quality systems specialists, partner with Manufacturing, QC, Engineering, and Supply Chain, and support inspection readiness and regulatory inspections.

Qualifications

• Bachelor’s degree in science/engineering/biotech/pharmacy or related field is required.
• Minimum 10 years of quality experience in a cGMP manufacturing facility; sterile manufacturing preferred.

Responsibilities

• Provide quality systems oversight for the CAR-T manufacturing site.
• Oversee Quality Systems, Systems Support, and Investigations teams to meet goals and deadlines.
• Lead cross-functional risk assessments (e.g., FMEA, hazard analysis) to identify, evaluate, and mitigate risks.
• Monitor metrics, backlogs, and effectiveness of CAPAs and investigations.
• Support regulatory inspections and audit readiness activities.

Skills

Quality leadership

Regulatory inspections

GxP compliance

CAPA investigations

Cross-functional collaboration

Project management

Education

Bachelor’s degree in Science/Engineering/Biotechnology/Pharmacy/Information Science/Biology or related

Advanced degree preferred

Tools

Quality Management System (QMS)

Job description

Legend Biotech USA Inc. in Raritan, New Jersey, is seeking an Associate Director, Quality Systems to lead the Quality Systems function for a CAR-T manufacturing site.

The role drives investigations, CAPAs, change control, and site quality metrics to ensure regulatory compliance in a sterile GMP environment. The candidate will manage a team of quality systems specialists, partner with Manufacturing, QC, Engineering, and Supply Chain, and support inspection readiness and regulatory inspections.