Director, CAR‑T QA Operations

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

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Paid parental leave

Job summary

Legend Biotech in Bridgewater, New Jersey, is seeking a Director, QA Operations to lead the Quality Operations team for CAR‑T cell therapy manufacturing. This role ensures cGMP compliance across disposition, batch records, and QC lab oversight, while developing long‑term quality programs and driving continuous improvement.

The candidate will manage senior managers, collaborate across sites, and align Quality Policies with business needs.

Qualifications

• Bachelor’s degree in Science, Information Science or equivalent technical discipline.
• Minimum 14 years of relevant work experience in aseptic manufacturing or quality-related roles.
• Knowledge of cGMP regulations and FDA/EU guidance for cell therapy products.
• Strong interpersonal and written/oral communication skills.
• Experience with quality systems and leading teams.

Responsibilities

• Manage daily quality activities for the QA operations team to ensure compliance with cGMP.
• Partner with Legend functional leaders to harmonize Quality Policies and Systems.
• Oversee incoming/final product disposition and batch record review at the site.
• Provide quality oversight of the QC laboratory and drive continuous improvement initiatives with the team.

Skills

Quality management

cGMP knowledge

Written and verbal communication

Leadership experience

Problem solving

Education

Bachelor’s Degree in Science or equivalent

Tools

Microsoft Office

Job description

Legend Biotech in Bridgewater, New Jersey, is seeking a Director, QA Operations to lead the Quality Operations team for CAR‑T cell therapy manufacturing. This role ensures cGMP compliance across disposition, batch records, and QC lab oversight, while developing long‑term quality programs and driving continuous improvement.

The candidate will manage senior managers, collaborate across sites, and align Quality Policies with business needs.