CQV Lead - Cell Therapy Manufacturing

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

Job summary

Legend Biotech in Bridgewater, NJ seeks a CQV Supervisor to lead commissioning, qualification, and validation activities for a cGMP cell therapy facility. You will oversee qualification programs, vendor coordination, and inspection readiness to ensure validated, compliant operations across manufacturing and laboratory systems.

The role requires strong regulatory expertise, cross-functional leadership, and a focus on risk-based validation and continuous improvement in a fast-paced biopharma

Qualifications

• Bachelor’s degree in engineering, Life Sciences, Pharmaceutical Sciences, Biotechnology, Chemistry, Microbiology, or related technical discipline is required.
• Advanced degrees or relevant professional certifications are preferred.

Responsibilities

• Serve as SME for CQV and regulatory requirements (21 CFR Parts 11, 210, 211; EU GMP Annex 11; Annex 15; GAMP 5).
• Lead CQV activities for manufacturing and laboratory equipment, systems, and facilities.
• Manage multiple CQV projects, timelines, and compliance priorities across cross-functional teams.
• Coordinate with Engineering, Manufacturing, Quality, Facilities, Automation, IT, and external vendors.
• Lead investigations, CAPAs, deviations, and remediation activities; support inspections and audits.
• Develop and maintain validation lifecycle documentation (plans, protocols, reports, periodic reviews).
• Drive risk-based validation, continuous improvement, and data integrity initiatives.

Skills

Regulatory compliance

Quality systems

cGMP

Data integrity

Education

Bachelor’s degree in engineering, life sciences, biotechnology, or related discipline

Tools

Maximo

Siemens EMS

Comet

Kneat

Summit

Job description

Legend Biotech in Bridgewater, NJ seeks a CQV Supervisor to lead commissioning, qualification, and validation activities for a cGMP cell therapy facility. You will oversee qualification programs, vendor coordination, and inspection readiness to ensure validated, compliant operations across manufacturing and laboratory systems.

The role requires strong regulatory expertise, cross-functional leadership, and a focus on risk-based validation and continuous improvement in a fast-paced biopharma