QA Validation & Equipment Compliance Manager

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**Date**:May 30, 2026 **Department**:Quality Operations Italy, Parma Site **Job Type**:Direct Employee **Business Area**:Quality **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 Vantaggi 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 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. Global TechOp&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**
- Provide Quality oversight and formal approval for qualification and validation activities in full compliance with applicable regulatory requirements and guidelines. Lead and control the site Validation Program, covering equipment, processes, utilities, facilities, computerized systems, cleaning procedures, and laboratory instruments, ensuring that products consistently perform as intended and meet predefined quality standards.
- Ensure regulatory and GMP compliance in the management of validation and qualification processes, including oversight of manufacturing and laboratory equipment throughout their lifecycle.
- Guarantee Data Integrity compliance across all site computerized systems by ensuring proper execution and governance of Computerized System Validation (CSV) activities. The scope applies to all GMP areas of the site and extends across both Active Pharmaceutical Ingredient (API) and Finished Product manufacturing operations. **You’ll be responsible for**: - Key Responsibilities- Support the Quality Management in defining, allocating, and monitoring the budget related to departmental projects and initiatives.
- Contribute to workforce planning by assessing required FTEs and identifying necessary competencies.




- Define and maintain the internal organizational structure, including roles, responsibilities, and job assignments.
- Set and assign qualitative and performance objectives in alignment with the company’s MBO system.
- Promote team development through tailored training plans and coaching programs based on individual needs.
- Ensure that managed personnel remain aligned with corporate competency frameworks and organizational behaviors.
- Monitor adherence to company values, code of conduct, ethical standards, and applicable legal and contractual requirements.
- People Management & Operational Oversight- Manage personnel in compliance with labor laws, contractual obligations, and workplace health and safety regulations; plan and coordinate team activities and support issue resolution.
- Ensure operational efficiency and safety of departments, facilities, and equipment by planning and overseeing required maintenance activities and implementing actions to minimize health and safety risks.
- Propose necessary investments to maintain safety, compliance, and operational effectiveness.
- Health, Safety & Compliance- Ensure fulfillment of mandatory information, training, and employee instruction obligations in accordance with applicable health and safety regulations.
- Collaborate with the EHS Department in the preparation and update of the departmental Risk Assessment Document (DVR).
- Implement and oversee risk control measures, including emergency procedures and evacuation protocols in case of serious and imminent danger.
- Verify proper use and adequacy of collective protective measures and personal protective equipment (DPI), ensuring timely replacement when necessary.
- Promptly report to the employer any irregu

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