CQV Supervisor - Cell Therapy Manufacturing & Validation

HireLifeScience; Raritan (NJ); On-site; USD 111,000 - 145,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) with match

Parental Leave

Job summary

Legend Biotech USA Inc. in Bridgewater, New Jersey, seeks an experienced CQV Supervisor to lead commissioning, qualification, and validation activities for cell therapy manufacturing facilities.

You will ensure regulatory compliance, manage cross-functional teams, oversee validation lifecycle documents, and drive continuous improvement to support reliable production of CAR‑T and other therapies.

Qualifications

• Bachelor's degree in engineering, Life Sciences, Pharmaceutical Sciences, Biotechnology, Chemistry, Microbiology, or related technical discipline is required.
• Minimum of 8 years of progressive CQV/Quality/Engineering experience in regulated biopharma or cell therapy environments.

Responsibilities

• Serve as SME for CQV with global regulatory requirements (FDA/EU GMP).
• Lead commissioning, qualification, requalification, and validation activities for facilities, equipment, and systems.
• Coordinate with cross-functional teams and external vendors to ensure timely project execution.
• Develop and maintain validation lifecycle documentation (plans, protocols, reports, traceability).
• Drive remediation, CAPAs, change controls, and risk-based validation improvements.

Skills

CQV expertise

Regulatory knowledge

Leadership

Cross-functional collaboration

Education

Bachelor's degree in engineering or Life Sciences

Tools

Maximo

Siemens EMS

Comet

Kneat

Summit

Job description

Legend Biotech USA Inc. in Bridgewater, New Jersey, seeks an experienced CQV Supervisor to lead commissioning, qualification, and validation activities for cell therapy manufacturing facilities.

You will ensure regulatory compliance, manage cross-functional teams, oversee validation lifecycle documents, and drive continuous improvement to support reliable production of CAR‑T and other therapies.