Who we are looking for Position Overview The 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 functions You will be responsible for Global 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.
Data Risk Management: 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 integrity Supports 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 have 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 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 have Familiarity 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 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.
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.