CQV Lead: Cell Therapy Manufacturing & Validation

Legend Biotech US; Raritan (NJ); On-site; USD 111,000 - 145,000; Full time

Benefits offered by this job

Medical insurance

401(k) with company match

Paid parental leave

Job summary

Legend Biotech USA Inc. is seeking a CQV Supervisor for the Technical Operations team in Raritan, NJ.

You will lead commissioning, qualification, and validation activities across the cell therapy manufacturing platform, ensuring data integrity and regulatory readiness. The role requires CQV experience, strong collaboration with cross-functional groups, and the ability to drive continuous improvements in CQV processes and documentation.

Qualifications

• Bachelor’s degree in Science, Engineering or equivalent technical discipline.
• 7+ years in aseptic manufacturing, preferably cell therapy or QA.
• Experience with CQV processes and documentation.
• Strong written and verbal communication skills.

Responsibilities

• Execute commissioning, qualification, requalification and validation activities.
• Coordinate with cross-functional teams and external vendors.
• Lead CQV investigations and CAPAs.
• Prepare CQV protocols and summary reports with data integrity.
• Maintain change controls and SOPs related to CQV.
• Train junior staff and present work to audits.

Skills

CQV experience

cGMP knowledge

Project management

Data integrity

Documentation

Regulatory audits

Education

Bachelor’s degree in Science/Engineering

Tools

Maximo

Siemens EMS

Comet

Kaye AVS

Kaye Valprobe

Job description

Legend Biotech USA Inc. is seeking a CQV Supervisor for the Technical Operations team in Raritan, NJ.

You will lead commissioning, qualification, and validation activities across the cell therapy manufacturing platform, ensuring data integrity and regulatory readiness. The role requires CQV experience, strong collaboration with cross-functional groups, and the ability to drive continuous improvements in CQV processes and documentation.