CQV Supervisor, Cell Therapy Manufacturing

Legend Biotech EU; Raritan (NJ); On-site; USD 111,000 - 145,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan with company/RO

Paid parental leave

Job summary

Legend Biotech USA Inc. is seeking a CVQ Supervisor for the Technical Operations team in Raritan, NJ. The role focuses on commissioning, qualification, validation and ongoing CQV activities to enable safe, compliant production of personalized cell therapies.

Responsibilities include leading complex CQV projects, managing investigations and CAPAs, and ensuring data integrity across protocols and change controls. Strong documentation, communication, and team mentorship are essential.

Qualifications

• Bachelor’s degree in Science, Engineering or an equivalent technical discipline.
• 7+ years of relevant work experience, preferably in aseptic manufacturing and cell therapy.
• Experience with cGMP regulations and FDA/EU guidance for cell-based products.
• Strong communication and independent working capabilities.

Responsibilities

• Execute commissioning, qualification, requalification, validation and related maintenance activities.
• Manage multiple complex CQV projects with cross-functional teams and external contractors.
• Support CAPAs, investigations and remediation efforts.
• Author CQV protocols, summary reports and data for regulatory conformance.
• Develop and review change controls, SOPs and related documentation.
• Contribute to risk assessments, FMEAs, periodic qualifications and annual reviews.
• Train junior team members on CQV activities.
• Present CQV work to regulatory and internal audit teams.

Skills

CQV experience

Regulatory audits

CAPA management

Documentation skills

Education

Bachelor’s degree in Science/Engineering

Tools

Maximo

Siemens EMS

Comet

Kneat

Kaye AVS

Kaye Valprobe

Job description

Legend Biotech USA Inc. is seeking a CVQ Supervisor for the Technical Operations team in Raritan, NJ. The role focuses on commissioning, qualification, validation and ongoing CQV activities to enable safe, compliant production of personalized cell therapies.

Responsibilities include leading complex CQV projects, managing investigations and CAPAs, and ensuring data integrity across protocols and change controls. Strong documentation, communication, and team mentorship are essential.