Product Quality Lifecycle Management Lead

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. /p pAt 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. /p pDiversity 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. /p pbGlobal Technical Operations Supply /b /p pGlobal 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. /p h3This is what you will do /h3 pThe 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. /p h3You will be responsible for /h3 pbRunning the Lifecycle Management Governance: /b /p ul liRuns the Air/Care lifecycle management governance /li liRuns the Rare lifecycle management governance /li liConnecting with all SME’s and departments for the lifecycle management. /li liOpportunities for continuously improving the lifecycle management governance process. /li liEnsure the governance process is documented at Chiesi. /li /ul pbEscalation of Lifecycle Management: /b /p ul liWorking cross functionally across departments on ensure lifecycle management activities are followed up and prioritised accordingly. /li liReporting of progress/escalations to the VP of Product Quality Lifecycle Management /li liFollowing up on actions across the wider team for lifecycle management. /li /ul pbEstablishing Regulatory Requirements for Lifecycle Management: /b /p ul liEnsures lifecycle management compliance with global regulatory requirements (e.g., FDA, EMA, MHRA, WHO, PIC/S) and industry standards related to lifecycle management. /li liSupports inspection readiness and participates in regulatory inspections and audits related lifecycle management.Maintains awareness of evolving regulatory expectations and ensures timely updates to internal policies and practices. /li /ul pbInfluence and Collaboration: /b /p ul liWorks closely with RD, regulatory, industrialisation, manufacturing sites and quality to ensure consistent lifecycle management of Chiesi products. /li liProvides guidance and training to global and local teams on lifecycle management principles and practices. /li liFosters a culture of accountability and continuous improvement in lifecycle management across the organization. /li /ul h3You will need to have /h3 ul liBachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, Data Science, Quality Management). /li liExtensive experience (10+ years) in quality systems, data governance, and regulatory compliance in the pharmaceutical industry in global roles. /li liA broad understanding of lifecycle management principles, GxP requirements, and regulatory expectations. /li liProven track record in collaborative working and team building. /li liStrong skills in managing lifecycle management risks and implementing effective governance frameworks. /li liStrong project management, communication, and stakeholder engagement skills. /li liAbility to influence cross-functional teams and drive change in a matrixed environment. /li /ul h3We would prefer for you to have /h3 ul liProfessional experience across many areas associated with the pharmaceutical development/commercialisation of products. /li liFamiliarity with digital quality systems and platforms (e.g., Veeva, TrackWise, SAP). /li liExperience with data analytics tools and methodologies for risk identification and mitigation. /li liAbility to analyse complex data issues and make risk-based decisions /li /ul h3Location /h3 pThe primary work location is Parma (Italy). The role offers flexibility, allowing candidates to be based across Europe, with regular travel to Parma required. /p h3Budgeted Salary Range /h3 pThe budgeted salary range approved for this role is between €62.000 and €85.000. This range reflects the typical compensation expected for candidates with the experience and expertise required for the position. /p pFinal offer may vary based on the selected candidate's skills, experience, qualifications, overall profile, and internal equity considerations. /p pThis role is eligible to participate in an annual bonus scheme, subject to company and individual performance. /p pIn addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme. /p pThe package outlined above is based on the role being located in Italy. Where the role is offered in a different Country, the applicable salary, bonus and benefits will be aligned to the relevant local market and internal frameworks. Full details of the applicable package will be provided at the appropriate stage of the recruitment process. /p h3What we offer /h3 pNo matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way. /p pWe provide top‑class benefits, including comprehensive healthcare programs, work‑life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive. /p pChiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination. /p /p #J-18808-Ljbffr