CQV & CSV Lead for Cell Therapy GMP

Legend Biotech, Inc.; Raritan (NJ); On-site; USD 127,000 - 167,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid parental leave

Paid time off with holidays

Job summary

Legend Biotech USA Inc. seeks a CQV Manager for the Technical Operations team based in Raritan, NJ.

You will lead commissioning, qualification, and validation across facilities, utilities, equipment, and computerized systems to ensure compliant, validated operations for cell therapy manufacturing. You will oversee lifecycle documentation, coordinate audits and inspections, and drive continuous improvement in CQV processes.

Qualifications

• Bachelor’s degree in engineering, Life Sciences, Pharmaceutical Sciences, Biotechnology, Chemistry or Microbiology is required.
• Advanced degrees or relevant professional certifications are preferred.
• Minimum of 8 years of progressive CQV/CSV, Quality, Engineering, Manufacturing, or Compliance experience in regulated environments.
• Minimum of 5 years of leadership or supervisory experience, including management of personnel and projects.
• Strong knowledge of FDA and global regulatory requirements (e.g., 21 CFR Parts 11, 58, 210, 211; EU GMP) and ICH guidelines.
• Experience supporting regulatory inspections, audits, CAPAs, change controls, and lifecycle management of GMP systems.
• Experience in aseptic manufacturing environments and cell therapy/genetic therapies desirable.

Responsibilities

• Serve as SME for global regulatory requirements and industry standards (e.g., 21 CFR 11, EU GMP Annex 11).
• Partner with cross-functional teams to maintain CQV tools, procedures, and compliance strategies.
• Lead commissioning, qualification, requalification, and validation activities for equipment, systems, and facilities.
• Manage multiple CQV/CSV projects, ensuring alignment with timelines and regulatory expectations.
• Coordinate with Engineering, Manufacturing, Quality, Facilities, Automation, IT, and external vendors for project execution.
• Lead investigations, CAPAs, deviations and remediation activities to address compliance gaps.
• Develop and execute validation lifecycle documents (plans, protocols, reports, periodic reviews).
• Administer and maintain Qualification/Requalification programs to sustain validated status.

Skills

CQV/CSV expertise

Regulatory compliance

Leadership

Project management

Cross-functional collaboration

Education

Engineering degree

Life Sciences degree

Tools

Maximo

Siemens EMS

Comet

Kneat

Summit

Job description

Legend Biotech USA Inc. seeks a CQV Manager for the Technical Operations team based in Raritan, NJ.

You will lead commissioning, qualification, and validation across facilities, utilities, equipment, and computerized systems to ensure compliant, validated operations for cell therapy manufacturing. You will oversee lifecycle documentation, coordinate audits and inspections, and drive continuous improvement in CQV processes.