16 ott - Parma
Chiesi Farmaceutici
Business Area: Industrial Operations & HSE Job Type: Direct Employee Contract Type: Permanent 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. At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose.
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 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. 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.
Ensure the successful delivery of DCP/Device lifecycle management, scale‐up and industrialisation activities by providing technical leadership, project governance and oversight of validation, change implementation and risk management processes. Drive alignment across internal functions, external partners and manufacturing sites to secure compliance and business continuity. Lead industrialization and scale‐up projects for Device Constituent Parts (DCPs), coordinating cross‐functional activities and ensuring the successful execution of development, validation, and technology transfer activities.
Provide technical leadership for validation, change management, risk assessment, and industrial development activities across device platforms. Manage and coordinate cross‐functional projects involving R&D;, Quality, Regulatory Affairs, Engineering, Manufacturing Sites, and CMOs. Drive the preparation, execution, and review of validation plans, technical protocols, reports, and development studies supporting industrialization and lifecycle management initiatives.
Support problem‐solving investigations, root cause analyses, and the implementation of corrective actions to ensure product robustness and business continuity. Oversee the assessment and implementation of changes affecting Device Constituent Parts.
Collaborate with manufacturing sites and external partners to ensure alignment on technical strategies, process improvements, scale‐up activities, and lifecycle management initiatives.
Contribute to the preparation of technical documentation required to support regulatory submissions and compliance with Medical Device Regulation requirements. Monitor project risks, timelines, and deliverables, providing technical guidance and governance to support successful project execution. Promote continuous improvement initiatives aimed at enhancing device robustness, manufacturing reliability, supply continuity, and operational excellence. 8 -10 years in the industrialization, validation, and lifecycle management of medical devices and/or drug‐device combination products.
Strong engineering background and technical expertise combined with hands‐on experience in product development, industrialization, and manufacturing. Proven experience in leading cross‐functional technical projects involving Quality, Engineering, Manufacturing Sites, and external partners. Strong understanding of regulated environments, including validation practices, change management, risk assessment, and Medical Device Regulation requirements.
Demonstrated ability to support industrialization, scale‐up, technology transfer, and process improvement activities across multiple manufacturing sites and CMOs. Ability to translate technical data into sound recommendations and support decision‐making across multidisciplinary teams. Strong analytical and problem‐solving capabilities, including experience in investigations, root cause analysis, and implementation of corrective actions.
Ability to balance technical, quality, regulatory, timeline, and business considerations when managing complex projects and changes. Expertise in medical device quality, risk management, manufacturing, and regulatory frameworks, including ISO 13485, ISO 14971, cGMP, and related global regulatory requirements. Fluent in written and spoken English.
Remote working is possible with regular presence in Parma Availability for regular travel to manufacturing sites and external partners. 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 participate in an annual bonus scheme, subject to company and individual performance. In addition, we offer a comprehensive benefits package including company pension, private medical insurance, wellbeing programme, flexible benefits programme... We 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. company pension private medical insurance flexible benefits programme... robust relocation support performance bonuses benefits benchmarked against the external market flexible working arrangements remote work options tax assistance services for foreign colleagues annual bonus scheme 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. We 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. Chiesi 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.
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