NPSS Quality Assurance Manager

Philips International; Bengaluru; Hybrid; INR 1,500,000 - 2,100,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Philips is seeking an NPSS Quality Assurance Manager in Bengaluru to lead risk-based assurance for computerized systems in a regulated medical device environment. The role focuses on CSV/CSA, quality oversight, and audit readiness across the system lifecycle.

You will collaborate with IT, Quality, Regulatory, Cybersecurity, and project teams to ensure systems are validated, compliant, and inspection-ready, maintaining data integrity and robust lifecycle controls.

Qualifications

• Bachelor’s or master’s degree in engineering, CS, information systems, life sciences, quality, or a related technical field.
• 8+ years of experience in computerized systems, software quality, validation, quality assurance, or quality systems in regulated life sciences.
• Demonstrable hands‑on experience planning, authoring, executing, reviewing, and approving CSV or CSA deliverables for complex systems.

Responsibilities

• Provide quality oversight across the full computerized system lifecycle, including validation planning, risk assessment, and traceability.
• Develop, implement, and maintain computerized system validation deliverables, procedures, and guidance for CSV/CSA.
• Prepare for internal and external audits, and coordinate timely responses to observations.
• Lead cross‑functional resolution of complex quality and compliance issues, escalating significant risks when needed.

Skills

CSV/CSA

Quality Assurance

Stakeholder Leadership

Audit Readiness

Regulatory Compliance

GxP Knowledge

Data Integrity

Risk Assessment

Technical Writing

Agile/DevOps

Education

Engineering/CS/IS degree

Tools

ERP

QMS

LIMS

Automated Testing

Job description

NPSS Quality Assurance Manager

Lead and execute compliant, risk-based assurance for computerized systems that support medical device quality and business processes. This role combines hands-on Computer System Validation (CSV), quality oversight, stakeholder leadership, and audit readiness across the system lifecycle.

Focus CSV / CSA and Quality Assurance Experience 8+ years in regulated environments Work Model Office-based / Hybrid designation to be confirmed The opportunity As an NPSS QA Manager, you will own and strengthen the validation and assurance framework for non-product software and computerized systems used in a regulated medical device environment. You will partner with process owners, IT, Quality, Regulatory, Cybersecurity, Privacy, suppliers, and project teams to ensure systems are fit for intended use, compliant, inspection‑ready, and maintained in a validated state.

Your role

Provide quality oversight and consultancy across the full computerized system lifecycle, including intended use, classification, validation planning, requirements, risk assessment, supplier assessment, test strategy, traceability, release, change control, periodic review, incident and problem management, and retirement. Develop, implement, and maintain computerized system validation deliverables, procedures, and guidance for CSV and Computer Software Assurance (CSA). Collaborate effectively with project teams and the NPSS team, consistently applying current GxP standards. Apply a risk‑based, critical‑thinking approach that scales assurance activities to patient safety, product quality, data integrity, regulatory, and business risk. Author, review, and approve validation and assurance deliverables, including validation plans, requirements and specifications, risk assessments, protocols or test evidence, traceability documentation, deviations, reports, and validation summaries. Ensure electronic records, electronic signatures, audit trails, access controls, data migration, interfaces, backup and restore, and data integrity controls are appropriately assessed and verified where applicable. Advise projects using Agile, DevOps, cloud, SaaS, configurable platforms, ERP, QMS, manufacturing, analytics, and other enterprise applications on compliant lifecycle controls and objective evidence. Assess and leverage supplier documentation and automated testing evidence where justified through documented risk and quality decisions. Ensure validated systems remain in a controlled state through change impact assessments, periodic reviews, issue and CAPA management, and lifecycle monitoring. Prepare for and support internal audits, external audits, and regulatory inspections. Present validation strategies and evidence and coordinate clear, timely responses to observations. Lead cross‑functional resolution of complex quality and compliance issues, facilitate risk‑based decisions, and escalate significant compliance risks when needed. Drive measurable improvements in validation efficiency, right‑first‑time quality, standardization, automation, and inspection readiness without weakening compliance controls. Coach and mentor validation engineers, validation leads, system owners, testers, and project team members, and develop or deliver role‑based training on lifecycle and assurance requirements.

You are the right fit if you have Bachelor’s or master’s degree in engineering, computer science, information systems, life sciences, quality, or a related technical field, or equivalent relevant experience. Minimum 8-12 years of relevant experience in computerized systems, software quality, validation, quality assurance, or quality systems within medical devices, pharmaceutical, biotechnology, diagnostics, or another highly regulated life sciences industry. Demonstrable hands‑on experience planning, authoring, executing, reviewing, and approving CSV or CSA deliverables for complex computerized systems. Strong working knowledge of risk‑based validation, data integrity, electronic records and signatures, configuration and change control, supplier assurance, and maintaining systems in a validated state. Experience supporting audits or inspections and explaining and defending validation strategies, risk decisions, and objective evidence to auditors or regulators. Ability to translate regulatory and quality requirements into practical controls for business, IT, and project teams. Excellent technical writing, facilitation, stakeholder management, and verbal communication skills in English. Ability to influence without direct authority, manage competing priorities, and make well‑reasoned quality decisions in a matrix organization.

Regulatory and industry knowledge

Candidates should bring practical knowledge of several of the following, with depth appropriate to the systems and markets supported: FDA Quality System Regulation / Quality Management System Regulation, including controls applicable to production and quality system software; 21CFR Part11 and EU GMP Annex11 principles for electronic records, electronic signatures, and computerized systems, where applicable; ISO13485 quality management system requirements and data integrity expectations; FDA Computer Software Assurance guidance and risk‑based assurance concepts; ISPEGAMP5 (A Risk‑Based Approach to Compliant GxP Computerized Systems) principles and recognized good practices for computerized system lifecycle management; Agile and DevOps delivery models, cloud and SaaS platforms, automated testing, and supplier‑managed services.

Preferred qualifications

Hands‑on experience validating enterprise platforms such as ERP, eQMS, PLM, MES, LIMS, CRM, data and analytics platforms, or regulated workflow applications. Experience working with validation workstreams, governance forums, remediation programs, or global process improvement initiatives. Professional certification or formal training in quality, auditing, software quality, validation, risk management, or project management. Experience with requirements, test management, electronic validation lifecycle management, or automated testing tools.

What success looks like

Validation strategies and deliverables are proportionate to risk, complete, traceable, and accepted right first time. Projects receive early, practical quality guidance and avoid late compliance rework. Systems remain inspection‑ready and in a validated state throughout their operational life. Audit and inspection questions are answered clearly with readily available, defensible evidence. Project teams adopt consistent, efficient assurance practices and demonstrate increased capability.

How we work together

We believe that we are better together than apart. For our office‑based teams, this means working in‑person at least 3 days per week. Onsite roles require full‑time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. Indicate if this role is an office/field/onsite role.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here. At Philips, we believe that every human matters. As a global health‑tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130years, we have been creating technologies and innovations that improve people’s lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health. Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment that we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success.

Equal Employment

It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism. To ensure reasonable accommodations for individuals protected by Section503 of the Rehabilitation Act of 1973, the Vietnam Veterans’ Readjustment Act of 1974 and TitleI of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact888‑367‑7223, option5, for assistance. Philips is an Equal Employment and Advancement opportunity including Disability/Vets and maintains a drug‑free workplace. Know Your Rights