NPSS Quality Assurance Manager
PhilipsThis role is no longer listed. Philips took the posting down on Sep 24, so applying now won't reach anyone. It stays here for your saved list and any links you shared.
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Protocol Intelligence
Data-driven signals on your job's competitivenessTier-1 brand and Bangalore metro increase applicant density, but niche CSV/regulatory skills limit competition.
Role requires regulated medical device/pharma CSV and regulatory knowledge, limiting cross-industry transferability.
Explicit 8–12 years, mandatory hands-on CSV/CSA and regulatory audit experience make shortlisting highly strict.
Job Description
Structured overview of role & requirementsAbout This Role
Lead and execute compliant, risk-based quality assurance and computer system validation (CSV/CSA) for non-product software in regulated medical device environments.
Own and maintain validation framework ensuring systems are fit for use, compliant, inspection-ready, and in a validated state throughout lifecycle.
Provide stakeholder leadership, audit readiness, and cross-functional resolution of complex quality and compliance issues, driving improvements in validation efficiency and inspection preparedness.
Minimum Requirements
8+ years of experience in computerized systems, software quality, validation, or quality assurance in regulated life sciences (medical devices, pharma, biotech, diagnostics).
Demonstrable hands-on experience planning, authoring, executing, and approving CSV or CSA deliverables for complex computerized systems.
Bachelor’s or master’s degree in engineering, computer science, information systems, life sciences, quality, or related technical field, or equivalent experience.
Work Model: Office-based / Hybrid designation to be confirmed.
Ideal Candidate Profile
Experienced in applying risk-based validation principles including GxP, 21 CFR Part 11, EU GMP Annex 11, ISO 13485, FDA CSA, and ISPE GAMP 5 guidelines.
Skilled in supporting audits/inspections by defending validation strategies and regulatory compliance with clear, defensible evidence.
Able to influence cross-functional teams in matrix organizations and translate regulatory requirements into practical lifecycle controls for Agile, DevOps, cloud, SaaS, and enterprise platforms.