Global Head of Quality Governance & Predictive Quality at Chiesi, focusing on quality governance framework and data-driven culture. Leading quality governance and predictive analytics across GxP operations.
Responsibilities
Possedere e guidare le strutture di governance della qualità globali, inclusi il Piano di Qualità e il framework del Quality Council a più livelli.
Agire come proprietario del processo per i processi di escalation e richiamo, garantendo la risoluzione tempestiva ed efficace delle problematiche qualitative.
Guidare il Tier 3 Global Quality Council, promuovendo allineamento strategico e decision-making attraverso la rete.
Armonizzare i dati KPI tra le operazioni GxP di Chiesi e sviluppare KPI dall fase III attraverso le filiali commerciali.
Sviluppare e implementare analisi predittive KPI per identificare proattivamente tendenze, rischi e opportunità di miglioramento.
Collaborare con i responsabili dei processi del sistema di qualità locale per promuovere le best practices, il miglioramento continuo e l'allineamento globale.
Garantire l'integrazione dei processi di governance con più ampi obiettivi di QMS e aziendali.
Requirements
Laurea in Farmacia, Scienze della Vita, Ingegneria o campo correlato
Almeno 15 anni di esperienza in sistemi di qualità farmaceutica
comprensione profonda delle normative GMP/GDP e principi di gestione del rischio di qualità
esperienza nelle ispezioni regolatorie e nei framework di conformità globali
forte coinvolgimento delle parti interessate e capacità di comunicazione
esperienza lavorativa e di leadership in un'organizzazione globale a matrice
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