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Novo Nordisk is a global healthcare company focused on developing treatments for obesity and diabetes, with more than 25 years of research in these areas. Founded in 1923, the company produces medicines intended to support patients across different stages of life and works to strengthen the safety and integrity of its products, including efforts to address falsified medicines. Its work spans pharmaceutical research, patient care, and broader efforts to improve access to essential treatment.
Senior IT Compliance Professional - Bagsværd Onsite
Senior IT Compliance Professional responsible for validating GxP systems, infrastructure, and emerging AI technologies at Novo Nordisk. Advises manufacturing IT and quality teams on risk-based compliance.
Description
- Help maintain compliant, reliable IT and automation systems for manufacturing operations
- Develop risk-based validation strategies for GxP systems, infrastructure, AI, and machine learning technologies
- Advise on validation plans, reports, test strategies, and related deliverables
- Participate in reviews as needed
- Represent the department in audits and inspections
- Coordinate the resolution of compliance gaps and findings
- Lead the implementation of new quality and regulatory requirements
- Provide compliance guidance to projects and operational teams as needed
- Maintain and streamline local processes, including SOPs, guides, training requirements, and supporting instructions
- Lead local projects and process-improvement initiatives
- Ensure operational management considerations are incorporated into IT projects
- Collaborate with local stakeholders, IT functions, quality teams, manufacturing sites, and external suppliers
- Participate in cross-site compliance and validation networks and work with global strategic partners
- Coach and mentor colleagues
Requirements
- Bachelor’s or master’s degree in computer science, engineering, life sciences, or a related discipline
- Three to five years of IT validation and compliance experience in a GxP-regulated environment
- Practical experience validating computerized systems and infrastructure
- Strong understanding of regulatory compliance, quality assurance practices, and GAMP 5
- Ability to communicate effectively with colleagues and management, take ownership, and deliver work independently
- Ability to achieve results across functions, cultures, and international virtual teams
- Sound business judgment when balancing different stakeholder interests
- Fluent English communication skills
- cGMP experience is advantageous but not required
- Experience validating AI or machine learning technologies is advantageous but not required
Benefits
- Ongoing learning opportunities
- Career growth and development
- Benefits aligned with your personal circumstances and career stage
- Potential short-term and/or long-term incentive plans
- Additional employee benefits determined by position level, location, functional area, and applicable market benchmarks
- Autonomy in your work and opportunities to contribute your perspective
- Practical development through new technologies, cross-site networks, and collaboration across functions
- Opportunities for coaching and mentoring
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