Biotech Quality Investigations Lead

Legendcareers; Raritan (NJ); On-site; USD 73,000 - 103,000; Full time

Job summary

Legend Biotech is seeking an Investigator I/II based in Raritan, NJ, to lead and manage moderate- to high-complexity quality investigations across manufacturing, facilities, equipment, validation, and related systems. You will collaborate cross-functionally to assess product quality, patient impact, and regulatory significance.

You will develop robust investigation reports, CAPAs, and effectiveness strategies, ensuring compliance with site procedures and data integrity standards while supporting

Qualifications

• BS/BA in engineering, science, or related field.
• 4-6 years of cGMP experience within biotechnology, biopharmaceutical, pharmaceutical, or other regulated industries, and/or 2-4 years of quality investigation experience.
• Experience conducting moderate- to high-complexity investigations, risk assessments, root causes, and CAPAs.
• Experience reviewing manufacturing, engineering, maintenance, calibration, environmental monitoring, and validation records.
• Excellent technical writing and documentation skills, and experience with regulatory inspections.

Responsibilities

• Independently lead end-to-end investigations related to manufacturing, facilities, equipment, validation, and other cross-functional quality events.
• Collect, review, and evaluate supporting investigation data and documentation.
• Conduct investigations related to facility and environmental monitoring excursions.
• Develop and own CAPA investigations with timely closure and effectiveness checks.
• Support internal audits and regulatory inspections with investigation findings.

Skills

Root cause analysis

CAPA development

Risk assessment

Cross-functional collaboration

Regulatory compliance

Data integrity

Investigations

Education

BS in engineering or science

Tools

eQMS

Microsoft Office

Job description

Legend Biotech is seeking an Investigator I/II based in Raritan, NJ, to lead and manage moderate- to high-complexity quality investigations across manufacturing, facilities, equipment, validation, and related systems. You will collaborate cross-functionally to assess product quality, patient impact, and regulatory significance.

You will develop robust investigation reports, CAPAs, and effectiveness strategies, ensuring compliance with site procedures and data integrity standards while supporting