Director, QA Operations – CAR-T Cell Therapy

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Paid parental leave

Job summary

Legend Biotech is seeking a Director, QA Operations in Raritan, NJ to lead the Quality Operations team for CAR-T cell therapy manufacturing. You will provide QA oversight, batch record review, and product disposition, ensuring strict adherence to cGMP and regulatory expectations.

The role requires deep knowledge of quality systems, aseptic processing, and regulatory requirements, plus strong leadership and collaboration across sites to drive continuous improvement and compliance.

Qualifications

• Bachelor’s degree in Science or equivalent technical discipline.
• 14+ years of relevant work experience in aseptic manufacturing/quality assurance or cell therapy.
• Knowledge of cGMP regulations and FDA/EU guidance for cell therapy products.
• Strong interpersonal and written/oral communication skills.
• Proven people management and leadership experience required.
• Experience with quality systems and regulatory documentation.

Responsibilities

• Manage daily quality activities for the QA operations team to ensure cGMP compliance.
• Partner with Legend leaders to align with Quality Policies and Systems.
• Oversee disposition of incoming materials and final product for the site.
• Review batch records and ensure accuracy and compliance.
• Lead quality shop floor programs and oversee QC laboratory quality.
• Develop continuous improvement initiatives across quality processes and teams.
• Lead a team of senior managers and professionals within QA and hire/develop staff.
• Coordinate quality systems activities across sites and functions to support business processes.
• Establish partnerships with other business units to link quality with operations.
• Ensure safety policies and cGMP requirements are followed.

Skills

Leadership

Quality systems

cGMP knowledge

Communication

People management

Problem solving

Documentation

Education

Bachelor’s degree in Science or equivalent

Tools

Microsoft Office

Job description

Legend Biotech is seeking a Director, QA Operations in Raritan, NJ to lead the Quality Operations team for CAR-T cell therapy manufacturing. You will provide QA oversight, batch record review, and product disposition, ensuring strict adherence to cGMP and regulatory expectations.

The role requires deep knowledge of quality systems, aseptic processing, and regulatory requirements, plus strong leadership and collaboration across sites to drive continuous improvement and compliance.