Product Quality Lifecycle Management Lead
Job Description & How to Apply Below
Department:
Corporate Quality Operations
Business Area:
Quality
Job Type: Direct Employee
Contract Type:
Permanent
Location:
Parma, IT
About us
Chiesi 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.
At 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.
Diversity 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.
Global Technical Operations & Supply
Global Technical Operations & Supply (Global Tech Op&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 Tech Op&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.
Ensure the governance process is documented alation 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…
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