Head of Global Data Integrity & Data Management

Head of Global Data Integrity & Data Management

Position 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 and drives a culture of proactive compliance in relation to data governance, transparency, and continuous improvement across all GMP/GDP functions.

You will be responsible for

Leading the global strategy for data integrity across the organization, ensuring alignment with regulatory expectations and internal quality standards.

Developing and implementing standardized policies and procedures for data governance, data lifecycle management, and data integrity controls.

Ensuring robust systems and processes are in place to prevent, detect, and correct data integrity issues.

Owning and overseeing the global data risk management program, identifying and mitigating risks related to data accuracy, completeness, consistency, and security.

Collaborating with cross‑functional teams to assess data‑related risks and implement appropriate controls.

Ensuring 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

Ensuring compliance with global regulatory requirements (e.g. FDA, EMA, MHRA, WHO, PIC/S) and industry standards related to data integrity.

Supporting inspection readiness and participating in regulatory inspections and audits related to data integrity.

Maintaining awareness of evolving regulatory expectations and ensuring timely updates to internal policies and practices.

Influence and Collaboration

Working closely with production sites, CMOs, and IT functions to ensure consistent implementation of data integrity practices.

Providing guidance and training to global and local teams on data integrity principles and practices.

Fostering 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 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.

We would prefer you to have

Familiarity with digital quality systems and platforms (e.g., Veeva, Track Wise, 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 :
Parma, Italy (Hybrid)

What we offer

We provide top‑class benefits including comprehensive healthcare programs, work‑life balance initiatives, robust relocation support, a competitive salary package, 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.

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