Legend Biotech
CQV Manager
$127K–$167K
Raritan, New Jersey, United States +1 · Manager · Full-time · Posted Oct 22, 2026
- Location
- Raritan, New Jersey, United States
United States - Experience
- Minimum 8 years of progressive relevant experience and minimum 5 years of leadership or supervisory experience.
- Education
- Bachelor’s degree in engineering, Life Sciences, Pharmaceutical Sciences, Biotechnology, Chemistry, Microbiology, or related technical discipline.
- Visa sponsorship
- Applicants must be authorized to work in the United States. The company participates in E-Verify.
About the job
Leads commissioning, qualification, and validation programs for a cGMP cell therapy facility, keeping facilities, equipment, utilities, computerized systems, and manufacturing processes compliant and validated.
What you'll do
- Oversee CQV and CSV projects, lifecycle documentation, qualification programs, and remediation activities.
- Lead investigations, CAPAs, change controls, risk assessments, and audit or inspection readiness.
- Coordinate cross-functional teams and vendors, and provide technical guidance to CQV personnel.
What they ask for
- Bachelor’s degree in a relevant technical discipline.
- At least 8 years of progressive experience in CQV/CSV, Quality, Engineering, Manufacturing, or Compliance in a regulated industry.
- At least 5 years of leadership or supervisory experience.
- Expertise in applicable FDA and global regulations, and experience with validation programs, inspections, investigations, CAPAs, and change controls.
Nice to have
- Advanced degree or relevant professional certifications.
- Aseptic manufacturing experience; cell therapy, CAR-T, biologics, tissue processing, quality assurance, or manufacturing compliance experience is highly desirable.
Pay
$127,313 — $167,099 USD (base pay)
Tools
Maximo, Siemens EMS, Comet, Kneat, Summit, Microsoft Office, Word, Excel
Model-written summary · the original posting is authoritative