Quality Investigations Lead

BioSpace; Raritan (NJ); On-site; USD 78,000 - 103,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) company match

Paid parental leave

Job summary

Legend Biotech in the United States is seeking an Investigator II to join the Technical Operations team in Raritan, NJ. The role leads moderate- to high-complexity quality investigations related to manufacturing, facilities, and validation, delivering robust reports, CAPAs, and regulatory-aligned outcomes.

The candidate will collaborate with SMEs and cross-functional stakeholders, support audits and inspections, and apply risk-based decision making to safeguard product quality and patient safety.

Qualifications

• BS/BA in engineering, science, or related field.
• 4-6 years of cGMP experience in biotech/pharma; or 2-4 years quality investigation experience.
• Experience conducting moderate- to high-complexity investigations and developing CAPAs.
• Strong technical writing and documentation for inspection-ready reports.
• Experience supporting regulatory inspections.

Responsibilities

• Lead end-to-end investigations related to manufacturing, facilities, engineering, and validation.
• Review supporting data: manufacturing records, equipment logs, environmental data, maintenance, validation docs.
• Prioritize workload based on business needs and product impact.
• Develop and own CAPA investigations with timely closure and effectiveness checks.
• Support internal audits and regulatory inspections and present findings.

Skills

Investigations

Root cause analysis

CAPA investigations

Cross-functional collaboration

Regulatory compliance

eQMS knowledge

Scientific writing

Data integrity

Education

BS/BA in engineering or science

Tools

Microsoft Office

eQMS software

Job description

Legend Biotech in the United States is seeking an Investigator II to join the Technical Operations team in Raritan, NJ. The role leads moderate- to high-complexity quality investigations related to manufacturing, facilities, and validation, delivering robust reports, CAPAs, and regulatory-aligned outcomes.

The candidate will collaborate with SMEs and cross-functional stakeholders, support audits and inspections, and apply risk-based decision making to safeguard product quality and patient safety.