Manager / Sr Manager Data Integrity Officer Navi Mumbai

Department: Quality Assurance/ Compliance

Position: Manager/ Sr. Manager - Data Integrity Officer

Role Summary

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.

Key Responsibilities

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

Qualifications

B.Pharm/M.Pharm, M.Sc. (Chemistry/Microbiology), or equivalent life sciences degree

815 years in pharma/biopharma QA, with 3+ years focused specifically on data integrity/compliance

Solid 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

Required Skill Profession

Operations Specialties Managers .