Head of NPSS E2E and Infrastructure SWM CoE

Job Title Head of NPSS E2E and Infrastructure SWM CoE Job Description Director, Non-Product Software Validation (NPSS) In this role you The Director, Non-Product Software Validation provides enterprise leadership for Quality Management Systems (QMS) Validation, regulatory compliance, and lifecycle governance of non-product software that support or interface with regulated business processes. The role ensures that validation, compliance, and risk-based controls are embedded throughout the system lifecycle and aligned with global regulatory requirements. Define and govern enterprise NPSS validation strategy, standards, controls, and operating models for regulated business and IT systems, including SAP ERP platforms. Lead validation planning, implementation, remediation, maintenance, change control, and retirement activities for enterprise applications supporting the Quality Management System (QMS). Ensure System Development Lifecycle (SDLC/SDLM) controls are implemented across automated processes that drive, interface with, or provide data to the Quality Systems. Drive Risk-based Computer System Validation (CSV) and Computer Software Assurance (CSA) practices to ensure compliance while enabling business agility. Provide subject matter expertise for SAP validation, enterprise applications, data integrity, electronic records, electronic signatures, and computerized-system governance. Lead inspection readiness, audit readiness, CAPA support, remediation activities, supplier corrective actions, and regulatory responses. Partner with Information Technology, Regulatory Affairs, Local QMSs Leadership, Business Process Owners, suppliers, and senior leadership to manage compliance risks and drive continuous improvement. Establish governance metrics and reporting mechanisms to monitor validation effectiveness, process adoption, compliance status, and enterprise risk. Enable digital transformation initiatives through compliant deployment and governance of enterprise applications while maintaining patient safety, product quality, and regulatory compliance. Build, coach, and lead high-performing and optimally engaged global teams responsible for validation, compliance, audit support, and process excellence. You're the right fit if 20+ years of experience in Medical Devices, Pharmaceuticals, Quality Assurance, Regulatory Compliance, Quality Systems, Computer System Validation, or regulated industries. Bachelor's or Master’s degree in engineering, Science, Quality Management, Information Technology, Electronics or related discipline. The ideal candidate will possess significant leadership experience building and managing globally distributed and cross-functional teams. Extensive experience leading NPSS validation programs and computerized-system implementations across enterprise in regulated environments. Demonstrates expertise in SAP ERP validation, including implementation, remediation, upgrades, maintenance, and lifecycle management. Having gone through multiple green field and brownfield SAP deployments. Proven experience supporting external regulatory inspections, internal audits, supplier audits, and quality-system assessments. Strong stakeholder-management, leadership, communication, negotiation, conflict resolution and organizational-influence capabilities. Experience driving CAPA, SCARS, change control, nonconformance management, process improvement, transformational programs, and audit readiness initiatives. Experience translating business processes into compliant technology solutions and governing enterprise-wide deployment of regulated applications. Technical and Regulatory Expertise Computer System Validation (CSV) /Computer Software Assurance (CSA) Quality Management Systems (QMS) – CAPA, SCAR, Deviation Management, Change Control SDLC / SDLM Governance, SAP ERP Validation GAMP 5, GxP Compliance for SaaS and non-SaaS Systems FDA 21 CFR Part 11, 820, 210, 211, QMSR ISO 13485, ISO 14971 IEC 62304 , AAME TIR36 EU MDR, EU Annex 11 Audit and Inspection Readiness Data Integrity Front Ending for Regulatory Inspections and Audits Process Excellence and Continuous Improvement, Six Sigma, ITIL How we work together We believe that we are better together than apart. For this role, it means working in-person at least 3 days per week. Compensation & benefits Doing meaningful work should come with fair, transparent rewards. The base salary range for this role is EUR 93,049 - EUR 155081.00 gross per year. We determine pay within the range using objective factors, like the skills the role requires, your relevant experience and the responsibility you'll have in this role, alongside internal equity and local market considerations. This role is eligible for 6% short term incentive with your rewards linked to both individual performance and company results. We’ll share the full approach with you during the interview process, so you can make a clear, informed decision. Benefits include hybrid working, paid time-off, health and wellbeing benefits, learning and development opportunities. Why should you join Philips? Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video . To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there,you can also learn about our recruitment process , or find answers to some of the frequently asked questions .