Quality Team Leader QA Operations

328728BR
France

Job Description

Have you ever heard of CAR-T cells? CAR-T cell therapy is a new type of immunotherapy based on innovative technology and is currently being widely developed to treat certain cancers. Our plant at Les Ulis, near Paris, is the leading CAR-T production facility in France.



Your Responsibilities Will Include But Are Not Limited To:
Responsible for operational leadership of Manufacturing, MS&T, Supply Chain, QC and aseptics within the site’s QA Operations unit. Ensure compliance with all cGxP, regulatory and HSE aspects as well as responsible for people leadership within are of responsibility.

Major accountabilities:
• Coordination of departmental operational activities within Manufacturing, QC, MS&T, Supply Chain area on behalf of Site QA Operations Lead (details see role profile QA Operations Lead)
• Provide oversight and monitoring on GMP operations onsite
• Supervision of site Batch Release Activities
• Line responsibility and daily walkthrough
• Lead OpEx Projects
• Investigation of Deviation, OOx, Complaints
• Define and implement CAPAs
• Support transfer projects & validation studies
• Track team metrics and ensure KQI/KPI meet requirements
• Review and approve GMP documents
• Define improvement areas in process and products
• Resource and capacity (people) planning and workload management
• Performance and leadership support to specialist team
• SOP review & revision
• Perform local training and monitor training status
• Planning of activities
• Daily supervision of activities
• Document approval
• Leading execution of daily plan

You will work with the week-end Team from Thursday to Sunday.

Diversity & Inclusion / EEO

Novartis s'engage à créer un environnement de travail exceptionnel et inclusif, ainsi qu'une équipe diversifiée, représentative des patients et des communautés que nous servons.

Minimum Requirements

Novartis s'engage à créer un environnement de travail exceptionnel et inclusif, ainsi qu'une équipe diversifiée, représentative des patients et des communautés que nous servons.
Novartis Technical Operations
NTO QUALITY
France
Ile-de-France
Quality
Temps partiel
90
Permanent
Non
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328728BR

Quality Team Leader QA Operations

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