For B. Braun’s Group Digital Department (GDD) we are looking for a Quality Manager (f/m/d) to support our computerized system validation activities.

Tasks and responsibilities:

• Develop, maintain, and improve processes, templates, and guidance for qualification and validation of computerized systems in accordance with GAMP 5 and internal requirements
• Support projects in planning and executing risk-based qualification and validation activities for computerized systems, including internally developed cloud services and web applications
• Create, review, and maintain qualification and validation documentation, such as plans, risk assessments, requirements, test documentation, traceability matrices, and reports
• Ensure qualification and validation requirements are appropriately integrated into system development, implementation, operation, and change management processes
• Develop and deliver training on qualification and validation processes and act as a subject matter expert within the GDD organization

Professional Qualifications:

• Degree in Computer Science, Engineering, Information Technology, Quality Management, or a comparable field
• Proven experience in Computerized System Validation (CSV), qualification, software quality assurance, or a related quality management discipline
• Good knowledge of GAMP 5 principles and risk-based qualification and validation approaches
• Experience with cloud-based services, computerized systems, and software development processes
• Ability to create and review qualification and validation documentation and quality procedures
• Strong written and verbal communication skills in English

Personal Qualifications:

• You have a sense for details, are driven to deliver and retain an overall perspective
• You can balance well between setting high quality standards and fast execution
• You are a self-starter, a continuous learner, and an explicit networker
• You have an agile mindset und enjoy working in a start-up environment