Manager, Data Management

08 ago - Italia
Chiesi Farmaceutici

Head of Global Data Integrity & Data Management
Corporate Quality Operations
Business Area: Quality
Contract Type: Permanent
Parma, IT
TheData Integrity & Data Mangement Leadis 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. 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
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.




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.
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

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