CQV Supervisor – Cell Therapy Manufacturing & Validation

Legendcareers; Raritan (NJ); On-site; USD 111,000 - 145,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) match

Parental leave

Job summary

Legend Biotech in Raritan, NJ is seeking a CQV Supervisor to support commissioning, qualification and validation for our cGMP cell therapy manufacturing facility. This role requires hands-on CQV, protocol management, vendor coordination, and remediation efforts to enable compliant production and product release.

The ideal candidate has a bachelor’s degree, 7+ years in aseptic manufacturing or cell therapy, plus strong knowledge of cGMP, data integrity, and regulatory expectations.

Qualifications

• Bachelor’s degree in Science, Engineering or equivalent.
• 7+ years of relevant experience in aseptic manufacturing or cell therapy.
• Experience with CQV, regulatory audits, and deviations.
• Knowledge of cGMP and FDA/EU guidance for cell-based products.
• Strong communication and project management skills.
• Experience with data integrity and documentation.

Responsibilities

• Execute commissioning, qualification, and validation activities in the plant.
• Lead multiple CQV projects and coordinate with cross-functional teams.
• Support investigations, CAPAs, and remediation.
• Author CQV protocols and summary reports.
• Present CQV work to regulatory and internal audit teams.
• Mentor junior team members.
• Manage deviations and change controls.

Skills

CQV experience

Cell therapy

cGMP knowledge

Regulatory audits

CAPA

Documentation

Vendor management

Project management

English language

Education

Bachelor’s Degree in Science/Engineering

Tools

Maximo

Siemens EMS

Comet

Kneat

Kaye AVS

Kaye Valprobe

Job description

Legend Biotech in Raritan, NJ is seeking a CQV Supervisor to support commissioning, qualification and validation for our cGMP cell therapy manufacturing facility. This role requires hands-on CQV, protocol management, vendor coordination, and remediation efforts to enable compliant production and product release.

The ideal candidate has a bachelor’s degree, 7+ years in aseptic manufacturing or cell therapy, plus strong knowledge of cGMP, data integrity, and regulatory expectations.