Lead BQA – GMQO (IT Systems Business Quality Assurance – Biometrics)
Location: Bangalore, Karnataka, India
Category: Manufacturing / Quality
Job Type: Full-Time
Job ID: R-95682
About the Company
Lilly is a global leader in healthcare and pharmaceutical innovation, committed to improving lives through groundbreaking research, advanced clinical development, and patient-focused solutions. Headquartered in Indianapolis, Lilly combines scientific excellence with a mission-driven culture, supporting communities worldwide through innovation, education, and responsible healthcare practices.
Position Overview
The Lead BQA – GMQO (IT Systems Business Quality Assurance – Biometrics) role is responsible for developing, implementing, and managing quality systems that support Data and Analytics and Global Statistical Science functions. This position acts as a trusted quality consultant, ensuring business processes align with global, regional, and local regulatory requirements.
You will ensure that IT systems used within clinical data flows meet compliance standards, quality expectations, and operational efficiency benchmarks. This role requires strong expertise in regulated environments, risk-based decision-making, and cross-functional collaboration.
Key Responsibilities
Quality Systems Implementation
Ensure the local implementation of the Safety and Efficacy Quality System (SEQS).
Review and compare regional/local SOPs with global policies and recommend updates.
Provide quality oversight to ensure alignment with global compliance requirements.
Escalate compliance issues to local and global leadership as needed.
Inspection Readiness and Compliance
Interpret pharmacovigilance regulations and serve as a compliance point of contact.
Conduct quality self-assessments and facilitate internal/external audits.
Support inspection readiness by ensuring documentation accuracy, organization, and accessibility.
Coordinate audit responses and manage Trackwise documentation.
Quality Planning and Process Excellence
Maintain regional/affiliate quality plans and clarify accountability structures.
Provide regular updates to business and quality stakeholders.
Support deviation management, change control, and notifications to management.
Conduct root cause analysis and recommend corrective actions for process improvement.
Data and Metrics Management
Analyze quality and compliance trends to identify gaps and propose solutions.
Track and monitor deviations, CAPA closures, audit responses, and change controls.
Share best practices to drive continuous improvement and process simplification.
IT Quality Assurance Responsibilities
Review and approve documents related to IT system development and maintenance.
Fulfill all responsibilities outlined in IT Quality policies for computer systems.
Participate in the IT Change Control Board and manage system interfaces as needed.
Review and approve validation documentation and change requests for IT systems.
Confidentiality & Compliance
Ensure proper handling of confidential information including patient data, audits, and regulatory reports.
Maintain compliance with global, regional, and local regulatory frameworks.
Qualifications
Education
Bachelor’s or Master’s degree in Science or a Healthcare-related field.
Experience Requirements
Minimum 3 years of experience in Quality Assurance, Data Management, Statistics, or related regulated functions.
Demonstrated experience in applying and interpreting quality systems in regulated environments (GMP, GCP, or similar).
Strong written and verbal communication skills with the ability to influence stakeholders.
Proven ability to handle multiple tasks, prioritize effectively, and apply risk-based decision-making.
Core Competencies
Strong understanding of global quality frameworks and compliance systems.
Ability to drive cross-functional quality initiatives and maintain high operational standards.
Proficiency in audit facilitation, documentation, and digital quality tools.
Capability to lead quality discussions within IT system environments.
Equal Opportunity Statement
Lilly is committed to maintaining an inclusive workforce. Qualified individuals with disabilities may request necessary accommodations during the application process. The company upholds strict non-discrimination policies across all legally protected categories.
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