Validation & Equipment Compliance Manager

Job description

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 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 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. 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 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 cGMP-regulated environments. Strong knowledge of EU and FDA regulatory requirements, with direct exposure to regulatory inspections (e.g., FDA/DEA). Proven background in managing validated/qualified systems. Strong capability to define and execute strategies to effectively manage multiple projects simultaneously. Solid technical problem-solving skills, with the ability to assess risks and implement balanced, compliant solutions. High level of initiative, accountability, and decision-making ability, with capacity to work effectively with minimal supervision. Excellent teamwork and interpersonal skills, with the ability to build constructive relationships across all organizational levels. We would prefer for you to have Experience in Cleaning Validation is highly preferred. Technical Competences Validation, Qualification & Compliance Responsibilities Oversee the preparation and issuance of Validation Project Plans (VPP) and Validation Final Reports (VFR), actively contributing to their development. Supervise the preparation of Technology Transfer documentation, ensuring completeness and regulatory compliance. Lead validation and qualification activities by defining objectives and timelines, reviewing data, and identifying necessary corrective actions. Collaborate to the site equipment lifecycle management, ensuring proper execution of qualification, maintenance, and calibration plans. Perform QA review and approval of validation documentation throughout the equipment/instrument lifecycle (URS, DQ, FAT, SAT, IQ, OQ, PQ, PV). Support investigations of qualification deviations, identifying appropriate corrective actions and assessing regulatory and operational impact. Manage environmental validation activities and cleaning validation programs for manufacturing facilities. Ensure pharmaceutical transport compliance with GDP requirements through the issuance of shipping validation protocols and reports. Support new site projects by ensuring qualification and validation strategies meet regulatory and corporate standards. Contribute to the development of ongoing process verification plans and related documentation. Data Integrity, Risk Management & Process Validation Ensure Data Integrity compliance through review of Computerized System Validation (CSV) documentation and support periodic review plans. Support process risk assessments to identify Critical Process Parameters (CPPs), Critical Quality Attributes (CQAs), and define appropriate validation strategies. Coordinate cross-functional teams in performing risk assessments for new projects and regulatory submissions (major and minor changes), ensuring site compliance with regulatory authorities. Collaborate with Production to ensure compliance with GMP and production plans, supporting process validation and cleaning validation activities. Quality System & Continuous Improvement Support Site Quality in the investigation of complaints and quality events; define and implement CAPA plans resulting from audits and inspections. Issue and maintain procedures within the area of responsibility. Participate in self-inspections, regulatory authority inspections, and customer audits. Maintain and control the Validation Change Control Program for validated/qualified systems and the Validation Management System (VMS). Review and approve the Validation Master Plan (VMP). Act as SME for process validation topics, including process changes, cleaning validation, hold times, and analytical instrumentation qualification. Deliver training on Validation, Qualification, and Change Management processes. Drive continuous improvement initiatives aimed at streamlining validation processes and reducing non-value-added activities. Provide leadership and guidance for validation-related CAPA activities. Participate in Quality Risk Management activities, contributing to FMEAs and Risk Control Plans as Validation SME. Location Parma Budgeted Salary Range The budgeted salary range approved for this role is between €52.000 and €65.000 . 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. What we offer No matter where your path starts at Chiesi, it leads to inspiring possibilities. 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.