Director, QA Operations - Cell Therapy

Legend Biotech US; 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, based in the United States, seeks a Director of QA Operations to lead quality activities for CAR-T manufacturing. You will oversee disposition, batch records, and QC lab oversight, ensuring adherence to cGMP and regulatory requirements.

The role requires building senior- level teams, driving continuous improvement, and partnering with cross-functional leaders to harmonize quality programs and systems globally.

Qualifications

• Bachelor’s Degree in Science or equivalent technical discipline is required.
• Minimum 14 years relevant work experience, preferably in aseptic manufacturing.
• Knowledge of cGMP regulations and FDA/EU guidance for cell-based products.

Responsibilities

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

Skills

Quality oversight

Team leadership

cGMP knowledge

Regulatory knowledge

QA operations

Education

Bachelor’s Degree in Science or equivalent

Tools

Microsoft Office

Job description

Legend Biotech, based in the United States, seeks a Director of QA Operations to lead quality activities for CAR-T manufacturing. You will oversee disposition, batch records, and QC lab oversight, ensuring adherence to cGMP and regulatory requirements.

The role requires building senior- level teams, driving continuous improvement, and partnering with cross-functional leaders to harmonize quality programs and systems globally.