CQV & CSV Manager, Cell Therapy Validation

BioSpace; Raritan (NJ); On-site; USD 127,000 - 167,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Paid parental leave

Vacation and PTO

Job summary

Legend Biotech, based in Raritan, NJ, seeks a CQV Manager to lead commissioning, qualification, and validation for a cell therapy manufacturing facility. You will guide CQV/CSV programs across facilities, utilities, equipment, and computerized systems to ensure compliant, validated operations and reliable production of therapies.

This role requires deep regulatory knowledge (FDA, EU GMP) and strong leadership to mentor teams, manage audits, and drive remediation of findings while maintaining a

Qualifications

• Bachelor’s degree in engineering, life sciences, or related field is required.
• Advanced degrees or professional certifications are preferred.
• Minimum 8 years of CQV/CSV or related experience in regulated environments.
• Minimum 5 years of leadership experience in cross-functional settings.
• Experience with FDA/global regulatory requirements and GMP is essential.

Responsibilities

• Serve as SME for CQV/CSV per global regulatory requirements.
• Lead and supervise CQV/CSV activities for equipment and systems.
• Coordinate cross-functional teams to ensure timely project execution.
• Manage regulatory audits, deviations, CAPAs, and change controls.
• Develop validation plans, protocols, reports, and lifecycle docs.

Skills

CQV/CSV leadership

Regulatory compliance

Process validation

Cross-functional collaboration

Project management

Education

Bachelor’s degree in engineering or life sciences

Advanced degrees preferred

Tools

Maximo

Siemens EMS

Comet

Kneat

Summit

Microsoft Excel

Office Suite

Job description

Legend Biotech, based in Raritan, NJ, seeks a CQV Manager to lead commissioning, qualification, and validation for a cell therapy manufacturing facility. You will guide CQV/CSV programs across facilities, utilities, equipment, and computerized systems to ensure compliant, validated operations and reliable production of therapies.

This role requires deep regulatory knowledge (FDA, EU GMP) and strong leadership to mentor teams, manage audits, and drive remediation of findings while maintaining a