Investigations Supervisor
Legend Biotech
August 26, 2026
On-site
Raritan, NJ
Operations
Role Overview:
The CAR-T Investigation Supervisor will work with the investigation team to identify true root cause of investigations and assess product quality impact. Provide technical support to investigators and resolution of deviations and atypical events. Recommend, own, and implement corrective/preventative measures to improve compliance, reduce repeat occurrences, and maintain consistent quality standards.
Key Responsibilities:
- Support area Manager and ensure investigations are completed on time and per guidelines.
- Assign investigations to team members 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 addressed root cause of NC events.
- Track deviations/events/key process parameters; report trending and status to management.
- Identify and implement process improvements for safety, environmental, quality, compliance, productivity, yield, and cost.
- Implement process improvements within the change control system.
- Recognize and act on compliance issues and process improvement opportunities.
- Partner with stakeholders to implement process improvements.
- Assure regulatory compliance and technical feasibility of proposed changes.
- Serve as project manager for change process and coordinate timely/compliant implementation.
- Act as SME for internal/external regulatory audits (FDA, EMEA).
- Maintain production information databases.
- Support data collection and trend analysis for QA/Regulatory Affairs (including SQC annual report and APR).
- Review and approve SOP and batch record revisions.
Requirements:
- BS/BA in engineering, science, or similar.
- 6+ years relevant professional experience.
- Experience completing complex investigations independently.
- Solid knowledge of cGMP and FDA/EU guidance.
- Ability to operate enterprise systems (eLIMS, TrackWise, Maximo, EMS, BMS, SAP).
- Excellent written/oral communication.
- Ability to respond to sensitive inquiries/complaints.
- Experience with internal/external regulatory audits.
- Ability to use standard programs for data entry/word processing.
- English.
Benefits:
- Medical, dental, vision; 401(k) with company match (vests day one); 8 weeks paid parental leave after 3 months; paid time off (vacation, personal, sick, floating holidays, 11 company holidays). Performance-based bonus and/or equity (eligible roles).
The CAR-T Investigation Supervisor will work with the investigation team to identify true root cause of investigations and assess product quality impact. Provide technical support to investigators and resolution of deviations and atypical events. Recommend, own, and implement corrective/preventative measures to improve compliance, reduce repeat occurrences, and maintain consistent quality standards.
Key Responsibilities:
- Support area Manager and ensure investigations are completed on time and per guidelines.
- Assign investigations to team members 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 addressed root cause of NC events.
- Track deviations/events/key process parameters; report trending and status to management.
- Identify and implement process improvements for safety, environmental, quality, compliance, productivity, yield, and cost.
- Implement process improvements within the change control system.
- Recognize and act on compliance issues and process improvement opportunities.
- Partner with stakeholders to implement process improvements.
- Assure regulatory compliance and technical feasibility of proposed changes.
- Serve as project manager for change process and coordinate timely/compliant implementation.
- Act as SME for internal/external regulatory audits (FDA, EMEA).
- Maintain production information databases.
- Support data collection and trend analysis for QA/Regulatory Affairs (including SQC annual report and APR).
- Review and approve SOP and batch record revisions.
Requirements:
- BS/BA in engineering, science, or similar.
- 6+ years relevant professional experience.
- Experience completing complex investigations independently.
- Solid knowledge of cGMP and FDA/EU guidance.
- Ability to operate enterprise systems (eLIMS, TrackWise, Maximo, EMS, BMS, SAP).
- Excellent written/oral communication.
- Ability to respond to sensitive inquiries/complaints.
- Experience with internal/external regulatory audits.
- Ability to use standard programs for data entry/word processing.
- English.
Benefits:
- Medical, dental, vision; 401(k) with company match (vests day one); 8 weeks paid parental leave after 3 months; paid time off (vacation, personal, sick, floating holidays, 11 company holidays). Performance-based bonus and/or equity (eligible roles).