Chiesi USA, Inc. · 15 hours ago
Head of Global Data Integrity & Data Management
Dublin, IN
Full-time
Hybrid
Director/Executive
15+ years expChiesi USA, Inc. is an international research-focused biopharmaceutical group committed to promoting a healthier world. The Head of Global Data Integrity & Data Management will lead the strategy for data integrity across the organization, ensuring compliance with global regulatory requirements and fostering a culture of proactive data governance and continuous improvement.
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
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 USA, Inc.
Chiesi USA is a pharmaceuticals company specializing in pharmaceutical research & development services.
201-500 employees
H1B Sponsorship
Chiesi USA, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2022 (1)
2021 (1)
Funding
Current Stage
Growth StageTotal Funding
$0MKey Investors
North Carolina Biotechnology Center
2020-08-04Grant· $0M
Leadership Team
Jon Zwinski
Chief Executive Officer - General Manager
Molly Rice
Senior Human Resources Business Partner / Associate Director Human Resources
Recent News
Clinical Trials Arena
2024-05-24
Company data provided by crunchbase