CQV & CSV Lead - Cell Therapy GMP Validation

Legend Biotech US; 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

8 weeks paid parental leave

Job summary

Legend Biotech US is seeking a CQV Manager to lead commissioning, qualification, and validation activities for a cutting-edge cell therapy manufacturing facility in Raritan, NJ. You will provide technical leadership, ensure regulatory compliance, and oversee validation of facilities, utilities, equipment, and computerized systems.

The role requires 8+ years in CQV/CSV, strong leadership, and deep knowledge of FDA/EU regulations.

Qualifications

• Bachelor’s degree in engineering or related field required.
• Minimum of 8 years CQV/CSV, Quality, Engineering, or Compliance experience in regulated environment.
• Minimum 5 years of leadership or supervisory experience with cross-functional teams.
• Demonstrated expertise in FDA/global regulatory requirements and audits (21 CFR parts 11, 58, 210, 211, 1271; EU GMP).

Responsibilities

• Serve as SME for CQV/CSV per global regulatory standards (21 CFR, EU GMP).
• Lead CQV/CSV projects, timelines, and cross-functional collaboration across Engineering, Manufacturing, Quality, Facilities, IT.
• Author, review, and execute validation lifecycle docs (VMPs, IQ/OQ/PQ, SOPs).
• Manage deviations, CAPAs, change controls, and risk-based remediation plans.
• Represent CQV/CSV in internal and regulatory audits; drive inspection readiness.
• Mentor CQV staff and drive continuous improvement of validation programs.

Skills

CQV/CSV expertise

Regulatory compliance

FDA 21 CFR familiarity

CAPA management

Change controls

Risk assessments

Project management

Documentation skills

Data integrity

Validation systems tools

MS Office / Teams

Education

Bachelor’s degree in Engineering

Advanced degree or certifications (preferred)

Tools

Maximo

Siemens EMS

Comet

Kneat

Summit

Microsoft Office (Word/Excel/PowerPoint/Outlook/Teams)

Job description

Legend Biotech US is seeking a CQV Manager to lead commissioning, qualification, and validation activities for a cutting-edge cell therapy manufacturing facility in Raritan, NJ. You will provide technical leadership, ensure regulatory compliance, and oversee validation of facilities, utilities, equipment, and computerized systems.

The role requires 8+ years in CQV/CSV, strong leadership, and deep knowledge of FDA/EU regulations.