Legend Biotech
CQV Supervisor
$111K–$145K
Raritan, New Jersey, United States · Full-time · Posted Sep 28, 2026
- Experience
- A minimum of 7 years relevant work experience.
- Education
- A minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline is required.
- Visa sponsorship
- Applicants must be authorized to work in the United States; employment eligibility is verified through E-Verify.
About the job
Supervises commissioning, qualification, and validation activities supporting compliant cGMP cell therapy manufacturing operations.
What you'll do
- Execute and manage commissioning, qualification, requalification, validation, and related maintenance activities, protocols, and reports.
- Coordinate CQV projects with internal teams and vendors; support investigations, CAPAs, deviations, and remediation.
- Train junior team members and present CQV work during regulatory and internal audits.
What they ask for
- Bachelor’s Degree in Science, Engineering or equivalent technical discipline.
- Minimum 7 years relevant work experience.
- Knowledge of cGMP and cGTP requirements for cell-based products, including CAR-T manufacturing or cell processing.
- Experience with ICH and/or 21 CFR parts 210, 211, 1271; authoring and executing documentation such as SOPs and CQV protocols.
Nice to have
- Experience in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance.
- Experience with 21 CFR parts 600, 601, and 610.
Pay
$110,706 — $145,303 USD (base pay)
Tools
Microsoft suite, Maximo, Siemens EMS, Comet, Kneat, Kaye AVS, Kaye Valprobe, ICH
Model-written summary · the original posting is authoritative