Apply on Employer Site

Chiesi Group · 1 month ago

Head of Global Data Integrity & Data Management

Dublin, IN

Contract

Hybrid

Director/Executive

15+ years exp

Chiesi Farmaceutici is an international research-focused biopharmaceutical group dedicated to promoting a healthier world. They are seeking a Head of Global Data Integrity & Data Management to develop and implement a robust data integrity program and ensure compliance with global regulatory requirements across the organization.

BiotechnologyMedicalPharmaceutical

Responsibilities

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

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

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

Qualification

Data IntegrityRegulatory ComplianceData GovernanceQuality ManagementRisk ManagementProject ManagementStakeholder EngagementContinuous ImprovementData AnalyticsDigital Quality SystemsCommunication SkillsCross-functional Collaboration

Required

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

Preferred

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

Benefits

Comprehensive healthcare programs

Work-life balance initiatives

Robust relocation support

Performance bonuses

Flexible working arrangements

Remote work options

Tax assistance services for foreign colleagues

Company

Chiesi Group

Glassdoor4.0

Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care.

Founded in 1935

Parma, Emilia-Romagna, ITA

5001-10000 employees