CQV Supervisor - Cell Therapy GMP Lead

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

Benefits offered by this job

Medical insurance

Paid parental leave

401(k) with company match

Job summary

Legend Biotech seeks a CQV Supervisor in Raritan, NJ to lead commissioning, qualification and validation for cell therapy manufacturing. You will manage complex CQV projects, interact with cross-functional teams and regulators, and oversee protocol development, data integrity and CAPA activities.

The role requires a Bachelor’s in science/engineering and at least 7 years in aseptic manufacturing or CQV, with strong communication skills and regulatory know-how.

Qualifications

• Bachelor’s Degree in Science, Engineering or equivalent technical discipline.
• 7+ years of relevant work experience in aseptic manufacturing or CQV.
• Experience with CQV activities and regulatory audits.

Responsibilities

• Execute CQV activities including commissioning, qualification and validation.
• Manage multiple CQV projects with cross-functional teams.
• Author CQV protocols, summary reports and data for regulatory conformance.
• Develop remediation plans and CAPAs; support change controls and SOP reviews.
• Provide training and guidance to junior team members.

Skills

cGMP knowledge

Regulatory knowledge

Strong communication

Education

Bachelor’s degree in Science/Engineering

Tools

Maximo

Siemens EMS

Comet

Kneat

Kaye AVS

Kaye Valprobe

Job description

Legend Biotech seeks a CQV Supervisor in Raritan, NJ to lead commissioning, qualification and validation for cell therapy manufacturing. You will manage complex CQV projects, interact with cross-functional teams and regulators, and oversee protocol development, data integrity and CAPA activities.

The role requires a Bachelor’s in science/engineering and at least 7 years in aseptic manufacturing or CQV, with strong communication skills and regulatory know-how.