NPSS Quality Assurance Manager

About the role

The NPSS Quality Assurance Manager will own and strengthen the validation and assurance framework for non‑product software and computerized systems used in a regulated medical‑device environment. Working from the Bangalore office, you will partner with IT, Quality, Regulatory, Cybersecurity, suppliers and project teams to ensure systems are fit for use, compliant and inspection‑ready.

Key responsibilities

• Provide quality oversight across the full computerized system lifecycle, from intended use and classification to retirement.
• Develop, implement and maintain CSV and CSA deliverables, procedures and guidance.
• Author, review and approve validation plans, risk assessments, protocols, test evidence, traceability documentation and validation summaries.
• Ensure electronic records, signatures, audit trails, access controls, data migration and backup controls are appropriately assessed.
• Advise Agile, DevOps, cloud, SaaS and enterprise application projects on compliant lifecycle controls.
• Lead cross‑functional resolution of complex quality and compliance issues and support internal and external audits.
• Coach and mentor validation engineers and system owners, delivering role‑based training.

Required profile

• Bachelor’s or master’s degree in engineering, computer science, life sciences or related field, or equivalent experience.
• 8‑12 years of experience in computerized systems, software quality, validation or quality assurance within medical devices, pharma or biotech.
• Hands‑on experience planning, authoring, executing and approving CSV/CSA deliverables for complex systems.
• Proven ability to support audits/inspections and defend validation strategies to regulators.
• Excellent technical writing, stakeholder management and communication skills in English.

Required skills

• Computer System Validation (CSV) and Computer Software Assurance (CSA).
• Risk‑based validation, data integrity controls, electronic records & signatures (21 CFR Part 11).
• Regulatory frameworks: FDA QSR, ISO 13485, ISPE GAMP 5.
• Agile and DevOps delivery models, cloud/SaaS platforms.
• Enterprise systems experience (ERP, eQMS, PLM, MES, LIMS, CRM, analytics platforms).
• Automated testing and supplier‑managed services.