Corporate Quality Operations Contract Type: Permanent Parma, IT Chiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. As a Agevolazioni Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. We believe our differences make us stronger. Global Technical Operations & Supply Global Technical Operations & Supply (Global TechOp&S;) is Chiesi's global manufacturing and supply area, responsible for ensuring consistent, outstanding quality, service and value across our end-to-end supply chain. Global TechOp&S; oversees the entire lifecycle of the drug: from process optimization and industrialization, to manufacturing, engineering, quality oversight, and supply chain management. Throughout this journey, Operational Excellence drives continuous improvement. This end-to-end model is powered by our four manufacturing sites
- Parma (IT), Blois (FR), Santana de Parnaíba (BR), and Nerviano (IT)
- together with our Virtual Plant network of external partners. This is what you will do The Product Quality Lifecycle Management Lead is an integral part of the Chiesi global organisation and located in the quality department. The position will have overall responsibility for the lifecycle management governance processes for Chiesi's Air/Care and Rare portfolio of products. This exciting role is a new position, and the successful candidate will have responsibility for implementing and improving the governance process. It will involve partnering primarily with R&D;, regulatory, industrialisation,



manufacturing sites and quality departments, however connectivity will occur across other departments (engineering and 3rd parties). The role will create a governance process that enables to manage its lifecycle of products in a proactive and collaborative manner across the organisation. You will be responsible for Running the Lifecycle Management Governance: Runs the Air/Care lifecycle management governance Runs the Rare lifecycle management governance Connecting with all SME's and departments for the lifecycle management. Opportunities for continuously improving the lifecycle management governance process. Escalation of Lifecycle Management: Working cross functionally across departments on ensure lifecycle management activities are followed up and prioritised accordingly. Reporting of progress/escalations to the VP of Product Quality Lifecycle Management Following up on actions across the wider team for lifecycle management. Establishing Regulatory Requirements for Lifecycle Management: Ensures lifecycle management compliance with global regulatory requirements (e.g., FDA, EMA, MHRA, WHO, PIC/S) and industry standards related to lifecycle management. Supports inspection readiness and participates in regulatory inspections and audits related lifecycle management. Influence and Collaboration: Works closely with R&D;, regulatory, industrialisation,



manufacturing sites and quality to ensure consistent lifecycle management of Chiesi products. Provides guidance and training to global and local teams on lifecycle management principles and practices. Fosters a culture of accountability and continuous improvement in lifecycle management across the organization. You will need to have Bachelor's degree in a relevant field (e.g., Life Sciences, Engineering, Data Science, Quality Management). Extensive experience (10+ years) in quality systems, data governance, and regulatory compliance in the pharmaceutical industry in global roles. A broad understanding of lifecycle management principles, GxP requirements, and regulatory expectations. Strong skills in managing lifecycle management risks and implementing effective governance frameworks. Strong project management, communication, and stakeholder engagement skills. Ability to influence cross-functional teams and drive change in a matrixed environment. We would prefer for you to have Professional experience across many areas associated with the pharmaceutical development/commercialisation of products. Familiarity with digital quality systems and platforms (e.g., Veeva, TrackWise, SAP). Experience with data analytics tools and methodologies for risk identification and mitigation. Ability to analyse complex data issues and make risk-based decisions The role offers flexibility, allowing candidates to be based across Europe, with regular travel to Parma required. This range reflects the typical compensation expected for candidates with the experience and expertise required for the position. Final offer may vary based on the selected candidate's skills, experience, qualifications, overall profile, and internal equity considerations. This role is eligible to par

📌 Product Quality Lifecycle Management Lead (Italia)
🏢 Biotecnologie - Farmacia - Chimica
📍 Italia