Head Of Global Data Integrity

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.Chiesi Global Manufacturing DivisionChiesi Group has three production plants:Parma (Italy), the strategic hub for the production and distribution of our products, serving as an international supply center with exports to over 80 countries.Here, solid medicines such as tablets and dry powders for inhalers, solutions and suspensions for inhalations and sterile suspension vials for endotracheal administration are produced.In ****, a new Biotech Centre of Excellence has launched in Parma.The new facility is dedicated to developing and producing monoclonal antibodies, enzymes, and other proteins.Blois-La Chaussée Saint Victor plant (France), a center of excellence specializing in the production of Dry Powder Inhalers and Metered Dose Inhalers (MDIs).The site manages direct distribution to customers in the French market and exports to other markets, effectively meeting both local and international needs.Santana de Parnaiba (Brazil), specialized in the production of pressurized solutions and suspensions for inhalation therapy (pMDIs).Additionally, it has an area dedicated to nasal sprays for the European market.Santana produces pressurised solutions and suspensions for inhalation therapy (MDI).In ****, a new investment in Nerviano (Italy) has been announced with the construction of a new facility which will be primarily dedicated to manufacturing carbon minimal inhalers (reinforcing the company's commitment to both patients' health and sustainable healthcare solutions), dry powder inhalers and sterile biological products.Chiesi is looking for dedicated professionals to help drive our mission and impact.Position OverviewThe Data Integrity & Data Mangement Lead is an integril part of the global quality orgnisation 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 will serve 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 functionsYou will be responsibleGlobal Data Integrity Governance:Leads the global strategy for data integrity across the organization, ensuring alignment with regulatory expectations and internal quality standards.Develops and implements standardized policies and procedures for data governance, data lifecycle management, and data integrity controls.Ensures robust systems and processes are in place to prevent, detect, and correct data integrity issues.Owns and oversees the global data risk management program, identifying and mitigating risks related to data accuracy, completeness, consistency, and security.Collaborates with cross-functional teams to assess data-related risks and implement appropriate controls.Ensures 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:Ensures compliance with global regulatory requirements (e.g., FDA, EMA, MHRA, WHO, PIC/S) and industry standards related to data integritySupports inspection readiness and participates in regulatory inspections and audits related to data integrity.Maintains awareness of evolving regulatory expectations and ensures timely updates to internal policies and practices.Influence and Collaboration:Works closely with production sites, CMOs, and IT functions to ensure consistent implementation of data integrity practices.Provides guidance and training to global and local teams on data integrity principles and practices.Fosters a culture of accountability and continuous improvement in data management across the organization.You will need to haveBachelor'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 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.We would prefer for you to haveFamiliarity with digital quality systems and platforms (e.g., Veeva, TrackWise, SAP).Experience with data analytics tools and methodologies for risk identification and mitigation.Ability to analyze complex data issues and make risk-based decisionsLocationHybrid – Parma, Dublin or other strategic locations in EuropeWhat we offerNo 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.#J-*****-Ljbffr