Director of QA Operations, CAR-T Cell Therapy

Legend Biotech USA, Inc.; Raritan (NJ); On-site; USD 194,000 - 254,000; Full time

Benefits offered by this job

Medical insurance

401(k) matching

Paid parental leave

Eight weeks of PTO

Job summary

Legend Biotech, based in Raritan, NJ, seeks a Director of QA Operations to oversee quality activities for CAR-T manufacturing. You will manage QA shop floor oversight, batch record reviews, and QC lab operations, driving continuous improvement and ensuring compliance with cGMP requirements.

The role requires a strong leadership background in aseptic manufacturing and extensive knowledge of quality systems, with the ability to coordinate across sites and functions.

Qualifications

• Bachelor's Degree in Science or equivalent.
• 14+ years in relevant quality roles preferred.
• Experience with cGMP and FDA/ICH guidance.
• Strong leadership and communication skills.

Responsibilities

• Oversee daily QA operations to ensure cGMP compliance.
• Partner with Legend leaders to align quality policies and systems.
• Manage disposition of incoming materials and final product.
• Review batch records and oversee QC lab activities.
• Drive continuous improvement of quality processes.

Skills

People leadership

Communication

Quality systems knowledge

Problem solving

Attention to detail

Education

Bachelor's Degree in Science

Tools

Microsoft Office

Job description

Legend Biotech, based in Raritan, NJ, seeks a Director of QA Operations to oversee quality activities for CAR-T manufacturing. You will manage QA shop floor oversight, batch record reviews, and QC lab operations, driving continuous improvement and ensuring compliance with cGMP requirements.

The role requires a strong leadership background in aseptic manufacturing and extensive knowledge of quality systems, with the ability to coordinate across sites and functions.