Manager Sr. Manager Data Integrity Officer

The Data Integrity Officer (DIO) is responsible for establishing implementing and overseeing data integrity governance across GxP systems (GMP GLP GCP) to ensure all data generated recorded processed and reported meets ALCOA principles and regulatory expectations (USFDA EMA MHRA WHO CDSCO). The role acts as the organization's subject-matter expert and escalation point for data integrity risks audits and remediation.

• Develop and maintain the organization's Data Integrity Policy SOPs and governance framework
• Conduct data integrity risk assessments across manufacturing QC labs and computerized systems (LIMS MES ERP SCADA)
• Lead/support data integrity audits (self-inspection vendor regulatory) and manage CAPAs
• Review audit trails electronic records and system access controls for anomalies
• Partner with IT/Validation teams on Computer System Validation (CSV) and 21 CFR Part 11 / Annex 11 compliance
• Train employees on data integrity culture ALCOA and reporting mechanisms
• Investigate data integrity breaches lead root cause analysis and drive corrective actions
• Liaise with regulatory bodies during inspections on data integrity matters
• Track industry trends/regulatory updates (FDA warning letters MHRA guidance) and update internal practices

• . (Chemistry/Microbiology) or equivalent life sciences degree
• 8–15 years in pharma/biopharma QA with 3 years focused specifically on data integrity/compliance
• Strong knowledge of 21 CFR Part 11 EU Annex 11 ALCOA GAMP 5 and data governance frameworks
• Experience with computerized system audits (LIMS ERP MES chromatography data systems)
• Prior exposure to USFDA/MHRA/EMA inspections is highly preferred