Senior Quality Investigator, Biotech Manufacturing

Legendcareers; Raritan (NJ); On-site; USD 84,000 - 110,000; Full time

Benefits offered by this job

401(k) with company match

Paid parental leave

Paid time off and holidays

Job summary

Legend Biotech is seeking an Investigator II to lead and manage moderate- to high-complexity quality investigations across manufacturing, facilities, equipment, and validation systems. You will assess product quality, patient impact, and regulatory significance, performing root-cause analyses and developing CAPAs.

You will collaborate with SMEs and cross-functional partners to resolve events, drive improvements, and ensure inspection readiness with robust documentation and risk-based thinking.

Qualifications

• BS/BA in engineering, science, or related field.
• 4–6 years of cGMP experience in biotech/pharma or 2–4 years in quality investigations.
• Ability to independently manage multiple concurrent investigations while meeting quality and timeliness expectations.
• Excellent technical writing and documentation skills.
• Working knowledge of eQMS and data integrity principles.

Responsibilities

• Lead end-to-end investigations related to manufacturing, facilities, engineering, equipment, validation, and other cross-functional quality events.
• Review, evaluate, and synthesize investigation data from multiple sources.
• Conduct facility and environmental monitoring investigations.
• Prioritize workload and adjust plans based on business needs and product impact.
• Develop and own CAPA investigations with timely closure and effectiveness checks.
• Support internal audits and regulatory inspections, including presenting findings.

Skills

Investigations leadership

Risk assessment

CAPA development

Root cause analysis

Technical writing

Cross-functional collaboration

eQMS proficiency

Regulatory knowledge

Data interpretation

Education

BS/BA in engineering or science

Tools

MS Office

eQMS

Job description

Legend Biotech is seeking an Investigator II to lead and manage moderate- to high-complexity quality investigations across manufacturing, facilities, equipment, and validation systems. You will assess product quality, patient impact, and regulatory significance, performing root-cause analyses and developing CAPAs.

You will collaborate with SMEs and cross-functional partners to resolve events, drive improvements, and ensure inspection readiness with robust documentation and risk-based thinking.