Overview Questa posizione è in Chiesi Group.
Il processo di selezione sarà gestito da Chiesi Group.
You will be responsible for 1. Digital Transformation of Pharma Operations Support digitalization across GMP processes in manufacturing, QC labs, QA systems, and supply chain.
Collaborate to implement and optimize key digital platforms: MES / electronic batch records (eBR) , LIMS and lab digital solutions , QMS platforms (deviations, CAPA, change control), Manufacturing automation, historian, SCADA/DCS .
Introduce data-driven and predictive tools (process monitoring, AI/ML models, real-time dashboards).
Collaborate with IT and QA to ensure Computer System Validation (CSV/CSA) and data integrity (ALCOA+) requirements are fulfilled.
2. Performance Management & Data Analytics Define KPI frameworks for manufacturing, quality, supply chain, and labs.
Build dashboards to monitor OEE, batch release cycle time, deviations, titer/yield, lab turnaround time, and supply chain performance.
Use advanced analytics to support root‐cause investigations and continuous performance improvement.
Ensure consistency, accuracy, and traceability of operational data across digital systems.
3. Operational Excellence Integration Partner with OE teams to integrate digital tools into Lean and continuous improvement programs.
Support initiatives to reduce deviation rates, shorten cycle times, improve yield, and optimize batch execution.
Drive cross-functional Kaizen and digital maturity roadmaps.
4. Change Leadership & Stakeholder Collaboration Work closely with Manufacturing, QA, QC, Process Engineering, Supply Chain, IT, and Digital/Automation teams.
Lead change management activities, including training, communication, and user engagement for new digital solutions.
Promote a culture of digital adoption, standardization, and continuous improvement.
5. Compliance, Validation & Governance Ensure alignment with GMP, GAMP 5, ICH, FDA/EMA regulatory expectations, and corporate quality standards.
Lead
📌 Digital Operations Analytics Manager (Italia)
🏢 Altro
📍 Italia