Novo Nordisk
Novo Nordisk
Novo Nordisk — семіздік пен диабетті емдеуге арналған препараттарды әзірлеуге бағытталған жаһандық денсаулық сақтау компаниясы. Компания бұл салаларда 25 жылдан астам уақыт бойы зерттеу жүргізіп келеді. 1923 жылы құрылған компания өмірдің әртүрлі кезеңдеріндегі пациенттерді қолдауға арналған дәрі-дәрмектер өндіреді және жалған дәрілермен күресу шараларын қоса алғанда, өнімдерінің қауіпсіздігі мен тұтастығын нығайтуға жұмыс істейді. Оның қызметі фармацевтикалық зерттеулерді, пациенттерге күтім көрсетуді және негізгі емдеу әдістеріне қолжетімділікті жақсартуға бағытталған ауқымды бастамаларды қамтиды.

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.

Сипаттама

  • 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

Талаптар

  • 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

Артықшылықтар

  • 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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