Product Quality Lifecycle Management Lead

5 ore fa

parma, emilia romagna, Italia Chiesi Farmaceutici S.p.A. Tempo pieno
ppDate: 25 Sept 2026 /ppDepartment: Corporate Quality Operations /ppBusiness Area: Quality /ppJob Type: Direct Employee /ppContract Type: Permanent /ppLocation: Parma, IT /ppbAbout us /b /ppChiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here. /ppAt Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. /ppDiversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better. /ppbGlobal Technical Operations Supply /b /ppGlobal Technical Operations Supply (Global TechOpS) 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 TechOpS 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. /ph3bThis is what you will do /b /h3pThe 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 RD, 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. /ph3bYou will be responsible for /b /h3pbRunning the Lifecycle Management Governance: /b /pulliRuns the Air/Care lifecycle management governance /liliRuns the Rare lifecycle management governance /liliConnecting with all SME's and departments for the lifecycle management. /liliOpportunities for continuously improving the lifecycle management governance process. /liliEnsure the governance process is documented at Chiesi. /li /ulpbEscalation of Lifecycle Management: /b /pulliWorking cross functionally across departments on ensure lifecycle management activities are followed up and prioritised accordingly. /liliReporting of progress/escalations to the VP of Product Quality Lifecycle Management /liliFollowing up on actions across the wider team for lifecycle management. /li /ulpbEstablishing Regulatory Requirements for Lifecycle Management: /b /pulliEnsures lifecycle management compliance with global regulatory requirements (e.g., FDA, EMA, MHRA, WHO, PIC/S) and industry standards related to lifecycle management. /liliSupports inspection readiness and participates in regulatory inspections and audits related lifecycle management. /liliMaintains awareness of evolving regulatory expectations and ensures timely updates to internal policies and practices. /li /ulpbInfluence and Collaboration: /b /pulliWorks closely with RD, regulatory, industrialisation, manufacturing sites and quality to ensure consistent lifecycle management of Chiesi products. /liliProvides guidance and training to global and local teams on lifecycle management principles and practices. /liliFosters a culture of accountability and continuous improvement in lifecycle management across the organization. /li /ulh3bYou will need to have /b /h3ulliBachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, Data Science, Quality Management). /liliExtensive experience (10+ years) in quality systems, data governance, and regulatory compliance in the pharmaceutical industry in global roles. /liliA broad understanding of lifecycle management principles, GxP requirements, and regulatory expectations. /liliProven track record in collaborative working and team building. /liliStrong skil