Investigations Supervisor, Biotech Quality & Compliance

BioSpace; Raritan (NJ); On-site; USD 111,000 - 145,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

8 weeks of paid parental leave

Paid time off and holidays

Job summary

Legend Biotech, based in Bridgewater, NJ, seeks an Investigations Supervisor for the Manufacturing & Supply team in Raritan, NJ. The role focuses on identifying true root causes of investigations and assessing product quality impact, with technical support to investigators and deviation resolution.

The position requires six years of relevant experience, knowledge of cGMP and FDA/EMEA guidance, and proficiency with enterprise systems including eLIMS, TrackWise, Maximo, EMS, BMS and SAP.

Qualifications

• BS/BA in engineering, science or similar field.
• Minimum of six years of professional experience.
• Experience completing complex investigations independently.
• Knowledge of cGMP regulations and FDA/EU guidance.

Responsibilities

• Support area Manager and investigators to ensure investigations are completed on time and per guidelines.
• Assign investigations to team members and track to completion.
• Follow up on investigations, Corrections, CPAs and Effectiveness checks.
• Review and approve SOP and Batch record revisions.

Skills

Investigations

cGMP knowledge

Regulatory audits

Communication

Data analysis

English

Education

BS/BA in engineering or science

Tools

eLIMS

TrackWise

Maximo

EMS

BMS

SAP

Job description

Legend Biotech, based in Bridgewater, NJ, seeks an Investigations Supervisor for the Manufacturing & Supply team in Raritan, NJ. The role focuses on identifying true root causes of investigations and assessing product quality impact, with technical support to investigators and deviation resolution.

The position requires six years of relevant experience, knowledge of cGMP and FDA/EMEA guidance, and proficiency with enterprise systems including eLIMS, TrackWise, Maximo, EMS, BMS and SAP.