IT Val. & Comp. Specialist I
Bangalore, Karnataka, IN
Department: Validation COE
Company: Novo Nordisk Global Business Services (GBS)
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.
Your new role
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.
Working at Novo Nordisk
Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations.
What we offer
There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.
Deadline- 10 July 2026
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.