Senior IT Validation and Compliance Specialist

As a Senior Validation & Compliance Specialist at Novo Nordisk, you will play a crucial role in ensuring compliance and validation in IT systems to safeguard patient safety and meet regulatory standards. Your responsibilities will include:

• Defining and executing risk-based validation strategies aligned with Novo Nordisk's Quality Management System, covering both Agile and V Model methodologies.
• Performing comprehensive assessments such as 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 as per the Software Testing Life Cycle (STLC).
• Leading end-to-end change management, conducting root cause analysis using the 5 x Why methodology, and managing CAPA processes during project and operation phases.
• Serving as Service Manager for multiple concurrent projects, overseeing 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 to optimize workflows and enhance operational efficiency.
• Experience in developing Merger and Acquisition strategies for large pharma organizations.
• Defining and executing a risk-based validation and AI assurance strategy aligned with Novo Nordisk QMS and AI governance frameworks.
• Serving as Subject Matter Expert for validation activities for traditional GxP computerized systems and AI/ML-enabled solutions across the product lifecycle.
• Ensuring the validated/compliant state is maintained throughout the system and model lifecycle including development, deployment, monitoring, and retirement.

Qualifications required for this role include:

• Bachelor's degree in computer science, Life Sciences, IT Quality, or a relevant field; industry-recognized ITIL and ISO quality management certification preferred.
• 8 years of experience in pharmaceutical or service-based organizations, with a focus on IT quality.
• Strong exposure to regulatory requirements such as GAMP 5, 21 CFR Part 11, and EU Annex 11.
• Practical experience in root cause analyses, CAPA, and other IT quality assurance activities, with expertise in validation for complex projects.
• 2 years of service management experience, including stakeholder management and service delivery across multiple concurrent projects.
• Proficiency in MS Office Suite, excellent coaching and mentoring capabilities, and strong time management skills.
• Fluency in English (written and oral) with excellent interpersonal, communication, and presentation skills across diverse cultures.

About the validation CoE team for ServiceNow, Integrations & Compliance within Novo Nordisk's Quality, IT, and Environmental Affairs department:

The Validation CoE team is responsible for compliance management of systems across various Novo Nordisk areas, supporting critical business processes globally. Your role will be essential in validating these systems and maintaining their compliance throughout their operational lifecycle.

At Novo Nordisk, you will be part of a company dedicated to defeating serious chronic diseases and creating lasting change for long-term health. You will have the opportunity to work in a diverse and inclusive environment that values shared purpose and mutual respect. Join us in our mission to make healthcare more accessible and pioneer solutions that impact generations. As a Senior Validation & Compliance Specialist at Novo Nordisk, you will play a crucial role in ensuring compliance and validation in IT systems to safeguard patient safety and meet regulatory standards. Your responsibilities will include:

• Defining and executing risk-based validation strategies aligned with Novo Nordisk's Quality Management System, covering both Agile and V Model methodologies.
• Performing comprehensive assessments such as 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 as per the Software Testing Life Cycle (STLC).
• Leading end-to-end change management, conducting root cause analysis using the 5 x Why methodology, and managing CAPA processes during project and operation phases.
• Serving as Service Manager for multiple concurrent projects, overseeing 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 to optimize