Sr IT Validation & Compliance Specialist I

Job description

Sr IT Validation Compliance Specialist I **Department:** Validation COE **Location:** Novo Nordisk Global Business Services (GBS) Are you passionate about ensuring compliance and validation in IT systemsDo you have the expertise to lead validation strategies that safeguard patient safety and ensure every system meets the highest regulatory standardsAre you passionate about integrating AI with process excellenceIf you are ready to take on a challenging and rewarding role, we invite you to join Novo Nordisk as our new Senior Validation Compliance Specialist. Read on and apply today! ### Job Summary ### Responsibilities - Defining and executing risk-based validation strategies aligned with Novo Nordisk's Quality Management System, acting as a subject matter expert across both Agile and V Model methodologies - Performing comprehensive assessments including IT Risk Assessments (ITRA), IT Requirements Risk Assessments (ITRRA), and quality, functional, data integrity and supplier assessments - Authoring, reviewing and executing end-to-end validation deliverables, managing test strategies and reporting in line with Software Testing Life Cycle (STLC) - Leading end-to-end change management, performing root cause analysis using 5 x Why methodology, and managing CAPA processes during both project and operation phases - Serving as Service Manager for multiple concurrent projects, managing service delivery, stakeholder relationships, and resource allocation across diverse international teams - Participating in audits and inspections, identifying compliance gaps and proposing solutions to maintain regulatory standards - Mentoring junior colleagues and driving process enhancements through automation strategies that optimise workflows and improve operational efficiency. - Take initiative to recognize, develop, and execute process enhancements and automation strategies (could be AI) that optimise workflows, reduce manual intervention, and drive operational efficiency. - Experience in developing Merger and Acquisition strtaegies for plarge pharma organizations . - Define and execute a risk-based validation and AI assurance strategy aligned with Novo Nordisk QMS and AI governance frameworks. - Serve as SME for validation activities for traditional GxP computerised systems and AI/ML-enabled solutions across the product lifecycle. - Ensure the validated/compliant state is maintained throughout system and model lifecycle including development, deployment, monitoring, and retirement. ### Qualifications We are looking for an experienced validation specialist who thrives in complex, regulated environments and enjoys driving compliance excellence. You'll bring with you: - Bachelor's degree in computer science, Life Sciences, IT Quality or a relevant field; industry-recognised ITIL and ISO quality management certification preferred - 8+ years of experience working in pharmaceutical or service-based organisations, preferably in the IT quality domain - 5+ years of practical experience in GxP areas with strong exposure to regulatory requirements including GAMP 5, 21 CFR Part 11, and EU Annex 11 - 5+ years performing root cause analyses, CAPA and other IT quality assurance activities, with proven expertise in validation for complex projects, 2+ years of service management experience, including stakeholder management and service delivery across multiple concurrent projects - Excellent coaching and mentoring capabilities, with the ability to guide junior colleagues and represent Novo Nordisk with users and external stakeholders - Proficiency in MS Office Suite and strong time management skills, combined with the flexibility to work under pressure and drive change processes - Fluency in English (written and oral) with excellent interpersonal, communication and presentation skills across diverse cultures #### Experience Level Senior Level 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.