QA Business Owner Data Integrity
$78,624–$117,936 year
On-site · Geel, Flanders, Belgium
Job Summary
QA Business Owner Data Integrity at Geel site leading strategic data-integrity direction, risk assessment, and CAPA execution within a GxP production environment. Acts as primary regulatory-inspection liaison, develops and delivers DI trainings, monitors digital application evolution (AI) for data-integrity practices, and represents the site in the Global COE. Responsible for regular data quality controls, incident investigations (including potential breaches or falsifications), and driving continuous improvement; collaborates with multiple departments to embed a culture of robust data integrity aligned with ALCOA+/GAMP5 guidance and EU/FDA regulatory expectations. Benchmarks best practices industry-wide, participates in international conferences, and communicates DI metrics (e.g., DIMM) to management. Requires leadership, strategic thinking, and multilingual communication (Dutch and English). In return,Sanofi offers equal opportunities and a competitive salary range (€72,800–€109,200) with final compensation based on experience and location.
Required Qualifications
- 5-10 years experience in ensuring regulatory compliance for data integrity within a GxP environment
- Strong communication skills in Dutch and English
- Experience with regulatory guidelines (ALCOA+, GAMP5, EU GMP Annex 11, FDA 21 CFR Part 11)
- Ability to lead continuous improvement of data-integrity practices
- Training program development and delivery
- Capability to act as SME during regulatory inspections and audits
- Exposure to automated systems validation (LIMS, MES, etc.)
- Cross-functional collaboration across multiple departments
- Ability to benchmark industry best practices in data integrity
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