Senior Test and Validation Manager

1 tydzień temu

Szczecin, West Pomerania, Polska Demant Polska Pełny etat

We are seeking an experienced
Senior Test and Validation Manager
to lead critical validation and testing activities across major
ERP transformation initiatives
ideally with previous experience in medical and production environment.

This role will focus on defining and executing validation strategies and leading comprehensive testing efforts to ensure system integrity and compliance with Demant's IT QMS and regulatory standards.

Working with us you will receive:

  • full-time work agreement in an international organization;
  • possibilities for learning and development opportunities, adapted to your needs and supporting your growth;
  • hybrid work model, combining remote work opportunities with work in an office in the Szczecin City Center;
  • flexible working hours;
  • benefits package including social benefits (private medical health care, insurance, sport card, etc.);
  • Scandinavian culture – we are informal and care about equality, independence, open dialog, and work-life balance.

What tasks are waiting for you?

  • Develop and drive end-to-end validation strategy for ERP systems, including planning, execution, and approval of validation deliverables.
  • Ensure adherence to SOPs for IT Computerized System Validation and HIQMS compliance.
  • Oversee creation and review of validation documentation (e.g., Validation Plans, IQ/OQ/PQ protocols, Traceability Matrix).
  • Define and lead the testing approach for ERP implementation, including functional, integration, and performance testing.
  • Establish test protocols, manage test environments, and ensure traceability between requirements and test cases.
  • Maintain validated state of systems during operation and manage change requests impacting validation scope.
  • Collaborate with Quality Assurance and IT Compliance and Validation teams to ensure regulatory compliance.
  • Work closely with Project Managers, Solution Architects, Business System Owners, and external vendors to align validation and testing activities with project timelines.
  • Provide expert guidance on risk-based validation strategies and testing best practices.

Apply today if you have:

  • Proven experience in IT system validation and testing ideally within regulated environments (GxP, EU-MDR, FDA).
  • Strong knowledge of ERP systems (preferably Microsoft Dynamics 365 Finance & Operations or similar).
  • Familiarity with validation frameworks (IQ/OQ/PQ), risk-based approaches, and documentation standards.
  • Excellent leadership, communication, and stakeholder management skills.

Nice to have: previous experience with Annex 11 and GAMP principles in production and medical environment

If you have any questions, contact the recruiter: Jakub )

Furthermore we would like to inform you that the company has an internal reporting procedure, which is available at: demantcompliance - Make a report )

Demant_Poland

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