SENIOR MANAGER

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Date: Jan 9, 2026

Location: Bangalore, KA, IN

Company: bioconbiolP2

Company Overview

Role Purpose

The Sr. Specialist – Quality – Data Governance is responsible for supporting the development, deployment, and maintenance of data governance frameworks, ensuring compliance with data integrity (DI) requirements across systems, processes, and records within GxP operations. This role collaborates across departments (QA, QC, Manufacturing, IT, Digital, Validation) to ensure ALCOA+ principles are applied consistently to paper-based and electronic data, supports audits/inspections, and drives continuous improvement in data quality, accessibility, security, and integrity.

Academic Stream

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Work experience (in months)

0

Job Responsibility and key Decisions

Support the implementation and monitoring of the data governance framework aligned with corporate and regulatory expectations.

Conduct or support Data Integrity DI assessments across departments to identify compliance gaps and improvement opportunities.

Monitor and report on compliance with data governance policies, including audit trail reviews and access control checks.

Participate in computerized system reviews, including audit trails, metadata evaluation, and electronic record controls.

Work with IT and QA to ensure data integrity is embedded into digital transformation projects and system implementations.

Review and support quality events deviations, CAPAs involving data issues, including root cause analysis and preventive measures.

Assist in developing and maintaining SOPs, templates, and guidelines for data handling, retention, and security.

Support training and awareness programs to build a data integrity culture across GxP functions.

Participate in audit readiness activities, mock inspections, and provide documentation for audits or regulatory inspections.

Analyze and report data integrity metrics and trends to management for continuous improvement.

Engage in crossfunctional initiatives such as digital quality systems upgrades or sitelevel data governance committees.

Identify and escalate data integrity risks or control gaps.

Recommend corrective actions for noncompliant data practices.

Decide on appropriate audit trail review frequency and focus based on system risk.

Support qualification of systems and processes from a data integrity standpoint.

Recommend updates or creation of procedures governing data practices.