Senior Quality Investigator – Biotech Operations

Legend Biotech, Inc.; Raritan (NJ); On-site; USD 90,000 - 125,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Parental leave

Paid time off

Job summary

Legend Biotech USA Inc. seeks an Investigator I/II to join the Technical Operations team in Raritan, NJ. The role focuses on independently leading and managing moderate- to high-complexity quality investigations across manufacturing, facilities, equipment, and validation systems.

You will perform root cause analyses, develop CAPAs, assess regulatory significance, and ensure data integrity. Collaboration with SMEs and cross-functional teams is essential for timely product disposition and

Qualifications

• BS/BA in engineering, science, or related field; 4–6 years cGMP in biotech or pharma preferred.
• Experience leading moderate- to high-complexity investigations with risk and CAPA.
• Strong writing, data review, and cross-functional collaboration skills.

Responsibilities

• Lead end-to-end investigations related to manufacturing, facilities, equipment, and validation.
• Review supporting data: manufacturing records, logs, environmental data, maintenance, validation docs.
• Perform risk assessments and determine product quality impact and regulatory significance.
• Develop CAPAs and ensure timely closure with effectiveness checks.
• Prepare concise, inspection-ready investigation reports for regulatory review.
• Collaborate with SMEs, Quality leads, and stakeholders to resolve events.

Skills

Quality investigations

Root cause analysis

CAPA development

Risk assessment

Cross-functional collaboration

Technical writing

Data review

Project management

Education

BS/BA in engineering, science, or related field

Tools

eQMS

Microsoft Office

Regulatory compliance systems

Job description

Legend Biotech USA Inc. seeks an Investigator I/II to join the Technical Operations team in Raritan, NJ. The role focuses on independently leading and managing moderate- to high-complexity quality investigations across manufacturing, facilities, equipment, and validation systems.

You will perform root cause analyses, develop CAPAs, assess regulatory significance, and ensure data integrity. Collaboration with SMEs and cross-functional teams is essential for timely product disposition and