Investigations Lead - GMP Compliance & QA

BioSpace; Raritan (NJ); Presencial; USD 111 000 - 145 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Resumo da oferta

Legend Biotech, based in Bridgewater, NJ, seeks an Investigations Supervisor to lead investigations within the Manufacturing & Supply team, identifying root causes and implementing corrective actions to improve compliance and product quality.

You will support investigators, manage case assignments, and coordinate deviations and change controls while ensuring regulatory readiness and data integrity across GMP processes.

Qualificações

• BS/BA required in technical discipline: engineering, science or similar field.
• Minimum six years of professional relevant business experience.
• Experience with internal and external regulatory audits.
• 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.

Responsabilidades

• Support area Manager and investigators to complete investigations on time per guidelines.
• Assign investigations and track to completion; follow up on status.
• Perform investigations and train new investigators.
• Collaborate to ensure corrective actions address root cause of NC events.
• Track deviations, events and process parameters; provide management reports.
• Identify process improvements for safety, quality, compliance and cost.
• Serve as SME for audits (FDA, EU) and ensure regulatory readiness.
• Maintain databases of production information and support data collection/trend analysis.

Conhecimentos

Investigations

Regulatory knowledge

Communication skills

Attention to detail

Formação académica

BS/BA in technical discipline

Ferramentas

eLIMS

TrackWise

Maximo

EMS

BMS

SAP

Descrição da oferta de emprego

Legend Biotech, based in Bridgewater, NJ, seeks an Investigations Supervisor to lead investigations within the Manufacturing & Supply team, identifying root causes and implementing corrective actions to improve compliance and product quality.

You will support investigators, manage case assignments, and coordinate deviations and change controls while ensuring regulatory readiness and data integrity across GMP processes.