NPSS Quality Assurance Manager

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 / 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;
• 21 CFR Part 11 and EU GMP Annex 11 principles for electronic records, electronic signatures, and computerized systems, where applicable;
• ISO 13485 quality management system requirements and data integrity expectations;
• FDA Computer Software Assurance guidance and risk-based assurance concepts;
• ISPE GAMP 5 (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.

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.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.