Validation & equipment compliance manager
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 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 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 will 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. 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. 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 irregularities or situations that may pose potential health and safety risks. You will need to have Bachelor's or Master's Degree in a scientific or engineering discipline (e.g., Chemistry, Pharmaceutical Chemistry and Technology, Engineering). Minimum 8–10 years of experience in pharmaceutical or biopharmaceutical manufacturing environments, within Engineering, Production, Process Technology, QA Validation, Technical Services or Quality Assurance functions. Extensive experience in validation and qualification of equipment and systems within c GMP-regulated environments. Strong knowledge of EU and FDA regulatory requirements, with direct exposure to regulatory inspections (e.g., Proven background in managing validated/qualified systems. Strong capability to define and execute strategies to effectively manage multiple projects simultaneously. High level of initiative, accountability, and decision-making ability, with capacity to work effectively with minimal supervision. We
- 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 will 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. 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. 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 irregularities or situations that may pose potential health and safety risks. You will need to have Bachelor's or Master's Degree in a scientific or engineering discipline (e.g., Chemistry, Pharmaceutical Chemistry and Technology, Engineering). Minimum 8–10 years of experience in pharmaceutical or biopharmaceutical manufacturing environments, within Engineering, Production, Process Technology, QA Validation, Technical Services or Quality Assurance functions. Extensive experience in validation and qualification of equipment and systems within c GMP-regulated environments. Strong knowledge of EU and FDA regulatory requirements, with direct exposure to regulatory inspections (e.g., Proven background in managing validated/qualified systems. Strong capability to define and execute strategies to effectively manage multiple projects simultaneously. High level of initiative, accountability, and decision-making ability, with capacity to work effectively with minimal supervision. We