CQV & CSV Program Lead, Cell Therapy

Legend Biotech USA, Inc.; Raritan (NJ); On-site; USD 127,000 - 167,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid parental leave

Paid time off

Job summary

Legend Biotech USA, Inc. is seeking a CQV Manager in Raritan, NJ to lead Commissioning, Qualification, and Validation for a cGMP cell therapy facility.

You will provide technical leadership across CQV/CSV programs, audits, and lifecycle management of validated systems, ensuring compliance and quality. In this role, you will mentor cross-functional teams, coordinate with Engineering, Quality, Facilities, and IT, and drive risk-based validation strategies to sustain manufacturing operations and

Qualifications

• Bachelor's degree in engineering, Life Sciences, Pharmaceutical Sciences, Biotechnology, Chemistry, Microbiology, or related technical discipline is required.
• Minimum of 8 years of progressive experience in CQV & CSV, Quality, Engineering, Manufacturing, or Compliance within a regulated pharmaceutical, biotechnology, cell therapy, or medical device environment.
• Minimum of 5 years of leadership or supervisory experience, including management of personnel, projects, contractors, and cross-functional teams.
• Demonstrated expertise in FDA and global regulatory requirements, including 21 CFR Parts 11, 58, 210, 211, and 1271, EU GMP regulations, EudraLex, and applicable ICH guidelines.
• Experience in aseptic manufacturing environments is highly preferred, with direct experience in cell therapy, CAR-T, biologics, tissue processing, quality assurance, or manufacturing compliance highly desirable.
• Language Requirements: English.

Responsibilities

• Lead CQV & CSV activities for manufacturing and laboratory equipment, computerized systems, automation platforms, process equipment, utilities, facilities.
• Oversee validation lifecycle documentation and change controls to ensure compliance and traceability.
• Represent CQV & CSV during internal audits, regulatory inspections, and inspection-readiness activities.
• Provide technical guidance and mentorship to CQV personnel and cross-functional stakeholders to promote a culture of quality and inspection readiness.

Skills

CQV & CSV leadership

Regulatory knowledge

Project management

Cross-functional leadership

Documentation & writing

Process improvement

Education

Bachelor's degree in engineering, Life Sciences, Pharmaceutical Sciences, Biotechnology, Chemistry, Microbiology, or related technical discipline

Advanced degrees preferred

Tools

Maximo

Siemens EMS

Comet

Kneat

Summit

MS Office

Job description

Legend Biotech USA, Inc. is seeking a CQV Manager in Raritan, NJ to lead Commissioning, Qualification, and Validation for a cGMP cell therapy facility.

You will provide technical leadership across CQV/CSV programs, audits, and lifecycle management of validated systems, ensuring compliance and quality. In this role, you will mentor cross-functional teams, coordinate with Engineering, Quality, Facilities, and IT, and drive risk-based validation strategies to sustain manufacturing operations and