NPSS Quality Assurance Manager

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About the role

Job Title NPSS Quality Assurance Manager Job Description Job Title: 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 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, biotechnolog

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