QUALITY SYSTEM AND COMPLIANCE SPECIALIST

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 Benefit 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. 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. The Quality & Compliance System Senior Specialist, within the Quality & Compliance System group, is responsible for managing inspections, training, documentation, site compliance, quality KPIs, and the preparation of master documents such as raw materials, materials, and finished product release specifications. The Quality & Compliance System Senior Specialist is responsible for the management and continuous improvement of the Quality Management System (QMS), with a particular focus on QMS-related projects. This key role ensures that all GMP-related processes are fully compliant with GMP standards, FDA and EU regulations, and internal company guidelines. Developing and Implementing Quality Management Systems (QMS): this includes creating and updating procedures, processes, and documentation to meet quality standards. Monitoring and Analyzing Quality Data: Prepare and submit periodic reports on the performance of the quality management system to company management Working with Cross-Functional Teams: collaborate with other departments (e.g., Quality System Governance: fostering a culture of quality and ongoing improvement throughout the site. Promote continuous improvements and share best practices, ensuring that quality activities are carried out in compliance with company procedures. Degree in scientific subjects (Chemistry, Pharmaceutical Chemistry and Technology, Engineering) At least 5 years of experience in manufacturing sites within the pharmaceutical and biopharmaceutical sector , specifically in Quality Assurance, Production, and Process Technology departments. Specialized expertise in GMP compliance improvement processes Fluent English (both written and spoken) Ability to establish strategies for managing multiple projects efficiently and effectively 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 pension, private medical insurance, wellbeing programme, flexible benefits programme. 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.