GMP Investigations Supervisor, Quality & Compliance

Legend Biotech, Inc.; Raritan (NJ); Vor Ort; USD 111.000 - 145.000; Vollzeit

Benefits dieser Stelle

Medical, dental, and vision insurance

401(k) with company match

8 weeks parental leave and generous PT

Paid time off & holidays

Zusammenfassung

Legend Biotech, Inc. is seeking an Investigations Supervisor in the Manufacturing & Supply team based in Raritan, NJ.

You will lead the investigations team to identify true root causes, assess product quality impact, and implement CAPAs, ensuring compliance and high-quality standards. The role requires six years of experience, strong cGMP knowledge, and ability to manage audits and change processes across systems like eLIMS, TrackWise, Maximo, EMS, BMS, and SAP.

Qualifikationen

• Six (6) years of professional relevant business experience.
• Experience completing complex investigations independently.
• Knowledge of cGMP regulations and FDA/EU guidance.
• Ability to learn and operate enterprise systems (eLIMS, TrackWise, Maximo, EMS, BMS, SAP).
• Excellent written and oral communication skills.
• Experience with internal and external regulatory audits.

Aufgaben

• Support area Manager and investigators to complete investigations on time per guidelines.
• Assign investigations and track to completion.
• Follow up on status of investigations, Corrections, CPAs and effectiveness checks.
• Perform investigations and train new investigators.
• Collaborate to determine if corrective actions address root cause of NC events.
• Provide reports on trending and status to management.

Kenntnisse

Investigations

cGMP knowledge

Regulatory audits

Data analysis

Project management

Communication skills

Ausbildung

BS/BA in technical discipline

Tools

eLIMS

TrackWise

Maximo

EMS

BMS

SAP

Jobbeschreibung

Legend Biotech, Inc. is seeking an Investigations Supervisor in the Manufacturing & Supply team based in Raritan, NJ.

You will lead the investigations team to identify true root causes, assess product quality impact, and implement CAPAs, ensuring compliance and high-quality standards. The role requires six years of experience, strong cGMP knowledge, and ability to manage audits and change processes across systems like eLIMS, TrackWise, Maximo, EMS, BMS, and SAP.