IT Val. & Comp. Specialist I

Job description

### Job Summary Help safeguard the systems that keep patient safety at the heart of everything we do. If you thrive at the intersection of compliance, technology and collaboration across borders, this is your opportunity to make complex GxP IT systems work seamlessly for millions of patients worldwide. ### Responsibilities As an IT Validation Compliance Specialist your day-to-day tasks will include: - Performing Computer System Validation (CSV) / Computer Software Assurance (CSA) activities in line with Novo Nordisk's Quality Management System for GAMP 5 Category 4 5 GxP computerised systems, including validation of AI features in GxP SaaS systems - Defining and executing risk-based validation strategies, acting as SME and championing critical thinking, cLean principles and faster releases - Supporting operational and maintenance activities such as Driving change and release management, including handling change requests, supporting system releases, and Coordinating incident and problem management for assigned systems, ensuring SLA KPIs are met and producing system-specific reports with corrective actions - Supporting periodic reviews, internal and external audits, deviation handling and creation of system documentation, SOPs, training material and user manuals - Managing vendor performance, negotiating Work Orders and SLA addendums, and resolving operational issues with suppliers and platform owners - Collaborating closely with System Owners, System Managers, IT/LoB SMEs, ITQA/ITQC and project team members in Denmark to ensure alignment and continuous improvement ### Your skills qualifications We are looking for a structured and business-oriented professional who enjoys working in an international matrix organisation, with the flexibility and team spirit to thrive in a dynamic environment. To succeed in this role, you will bring: - An MCA, MTech, BCA or similar graduate degree in a relevant field, or equivalent business experience, supported by documented supplementary training within your area of expertise - Minimum 6+ years' experience validating complex GxP IT systems with pharmaceutical requirements, including 4+ years specifically handling validation testing of complex GxP IT systems and experience supporting the Argus and Veeva Safety systems through releases, incident management and validation activities - Solid experience in IT Risk Assessment (Business Process, Solution, Data Integrity, IT Security, Functional and Supplier) and exposure to requirement and test management tools such as HP ALM or Azure DevOps (ADO) - Hands-on experience validating GAMP 5 Category 4 5 GxP IT/SaaS systems managed under agile and cLean methodologies (an added advantage), as well as fair experience in release management planning, execution and benefit realisation - Experience working with external vendors and stakeholders across multiple geographies and time zones, combined with excellent written and spoken English and a natural collaborative mindset ### Your new department In Quality, IT you will be part of a business area that drives impact across the full Novo Nordisk value chain. We strive to stay close to our stakeholders in the business to ensure we deliver on their needs, helping reach millions of people living with serious chronic diseases. Our focus is on being at the forefront within our three areas; ensuring the highest quality for patients, being a trusted tech leader and an environmentally responsible business. Within Quality, IT sits the Validation CoE team for ServiceNow, Integrations Compliance. Our unit is responsible for compliance management of systems across Novo Nordisk areas including International Operations, Enterprise IT Quality, Finance, Legal Global Solutions, Research Development, and CMC Product Supply. These systems operate on local, regional and global scales, supporting critical business processes in sales, marketing, production, development, manufacturing and finance. Your role will be essential in validating these systems and maintaining their validated state throughout their operational lifecycle. Disclaimer : This job posting & Location 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.