Head of Global Data Integrity

Overview Chiesi is an international research-focused biopharmaceutical group with 90 years of experience, operating in more than 30 countries, with its headquarters in Parma, Italy. The group employs more than 8,000 people united by the purpose of promoting a healthier world for people, patients, and the planet. Chiesi cultivates a culture of reliability, transparency, and ethical behavior and is a Benefit Corporation and a certified B Corp with sustainability embedded in its bylaws. Diversity and inclusion are central to our values. Chiesi Global Manufacturing Division includes plants in Parma (Italy), Blois-La Chaussée-Saint Victor (France), Santana de Parnaiba (Brazil), and a new Nerviano facility in Italy. In 2025, a new investment in Nerviano will support manufacturing of carbon minimal inhalers, dry powder inhalers, and sterile biological products. Chiesi is looking for dedicated professionals to help drive our mission and impact. Position Head of Global Data Integrity Data Management • Rome, Italy Role Overview The Data Integrity & Data Management Lead is an integral part of the global quality organization, responsible for developing, implementing, and maintaining a robust data integrity program across the organization to ensure compliance with global regulatory requirements (e.g., FDA, EMA, MHRA). This role serves as the subject matter expert (SME) for data integrity, driving a culture of proactive compliance in relation to data governance, transparency, and continuous improvement across all GMP / GDP functions. You will be responsible Global Data Integrity Governance: Lead the global strategy for data integrity across the organization, ensuring alignment with regulatory expectations and internal quality standards. Develop and implement standardized policies and procedures for data governance, data lifecycle management, and data integrity controls. Ensure robust systems and processes are in place to prevent, detect, and correct data integrity issues. Own and oversee the global data risk management program, identifying and mitigating risks related to data accuracy, completeness, consistency, and security. Collaborate with cross-functional teams to assess data-related risks and implement appropriate controls. Ensure data risk outcomes are regularly reviewed by senior management (e.g., via Quality Council or Risk Review Board meetings) and that improvement actions are defined and tracked. Compliance and Regulatory Alignment: Ensure compliance with global regulatory requirements (e.g., FDA, EMA, MHRA, WHO, PIC/S) and industry standards related to data integrity. Support inspection readiness and participate in regulatory inspections and audits related to data integrity. Maintain awareness of evolving regulatory expectations and ensure timely updates to internal policies and practices. Influence and Collaboration: Work closely with production sites, CMOs, and IT functions to ensure consistent implementation of data integrity practices. Provide guidance and training to global and local teams on data integrity principles and practices. Foster a culture of accountability and continuous improvement in data management across the organization. Qualifications Bachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, Data Science, Quality Management). Extensive experience (15+ years) in quality systems, data governance, and regulatory compliance within the pharmaceutical industry in global roles. Deep understanding of data integrity principles, GxP requirements, and regulatory expectations. Proven track record in managing data-related risks and implementing effective governance frameworks. Strong project management, communication, and stakeholder engagement skills. Ability to influence cross-functional teams and drive change in a matrixed environment. Familiarity with digital quality systems and platforms (e.g., Veeva, TrackWise, SAP) is preferred. Experience with data analytics tools and methodologies for risk identification and mitigation. Ability to analyze complex data issues and make risk-based decisions. Location Hybrid – Parma, Dublin or other strategic locations in Europe. What we offer No matter where your path starts at Chiesi, it leads to inspiring possibilities. We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, relocation support, and a competitive salary package with performance bonuses and market-aligned benefits. Flexible working arrangements, remote work options, and tax assistance services for foreign colleagues are available to help you thrive. Equal Opportunity Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels. All qualified applicants receive consideration for employment 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. #J-18808-Ljbffr