Hybrid Senior Test and Validation Manager

at Demant

• Job title: Senior Test and Validation Manager
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Tech skills: ERP
• Location requirements: Hybrid, Szczecin, Poland

About the role

• Senior Test and Validation Manager focusing on ERP systems validation and testing for Demant. Ensuring compliance with IT QMS and regulatory standards in the medical field.

Responsibilities

• 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.

Requirements

• 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.

Benefits

• 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.