GMP Investigations Lead, Quality & Compliance

Legend Biotech EU; Raritan (NJ); On-site; USD 111,000 - 145,000; Full time

Job summary

Legend Biotech is a global biotechnology company seeking an Investigations Supervisor for the Manufacturing & Supply team in Raritan, NJ. The role focuses on identifying root causes of investigations, supporting investigators, and implementing corrective actions to maintain quality standards.

The supervisor will coordinate with QA, Regulatory Affairs, and auditors (FDA/EMEA), manage deviations, and drive improvements across safety, compliance, productivity, and cost.

Qualifications

• Six (6) years of professional relevant business experience.
• Demonstrated experience in completing complex investigations independently.
• Knowledge of cGMP regulations and FDA/EU guidance.

Responsibilities

• Support area Manager and investigators to complete investigations on time per guidelines.
• Assign investigations to team members and track to completion.
• Review SOP and Batch record revisions and ensure compliance.

Skills

Investigations

Regulatory audits

Communication skills

Data analysis

Education

BS/BA in technical discipline

Tools

eLIMS

TrackWise

Maximo

EMS

BMS

SAP

Job description

Legend Biotech is a global biotechnology company seeking an Investigations Supervisor for the Manufacturing & Supply team in Raritan, NJ. The role focuses on identifying root causes of investigations, supporting investigators, and implementing corrective actions to maintain quality standards.

The supervisor will coordinate with QA, Regulatory Affairs, and auditors (FDA/EMEA), manage deviations, and drive improvements across safety, compliance, productivity, and cost.