CQV & CSV Validation Leader – Cell Therapy

legendcareers; Raritan (NJ); On-site; USD 130,000 - 190,000; Full time

Job summary

Legend Biotech is seeking a CQV Manager in Raritan, NJ to lead commissioning, qualification, and validation activities for a cGMP cell therapy manufacturing facility. The role provides technical leadership and oversight of CQV/CSV programs, ensuring systems stay validated, compliant and fit for use throughout the lifecycle.

The candidate will collaborate with Engineering, Manufacturing, Quality, Facilities, Automation, IT and external vendors to drive CQV excellence, manage deviations and CAPAs,

Qualifications

• CQV/CSV subject-matter expertise required (cGMP environments).
• Experience with 21 CFR Parts 11, 210, 211 and EU GMP guidelines preferred.
• Strong leadership of cross-functional teams across Engineering, Manufacturing, Quality, Facilities, Automation and IT.

Responsibilities

• Lead CQV/CSV activities for facilities, utilities, equipment, and computerized systems.
• Develop and execute qualification/validation plans and lifecycle documentation.
• Manage vendor/contractor relationships, deviations, CAPAs, and change controls.
• Ensure regulatory inspections readiness and robust risk-based CQV program.

Skills

CQV SME

Regulatory standards

Cross-functional leadership

GAMP 5

Job description

Legend Biotech is seeking a CQV Manager in Raritan, NJ to lead commissioning, qualification, and validation activities for a cGMP cell therapy manufacturing facility. The role provides technical leadership and oversight of CQV/CSV programs, ensuring systems stay validated, compliant and fit for use throughout the lifecycle.

The candidate will collaborate with Engineering, Manufacturing, Quality, Facilities, Automation, IT and external vendors to drive CQV excellence, manage deviations and CAPAs,