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
Benefits:
- Company pension scheme
- Mobility benefits, e.g., the B. Braun Job Ticket or Job Bike
- Family-support services, e.g., vacation childcare
- Flexible working hours such as flextime and mobile work
- Employee discounts
- Various working models, e.g., job sharing/part-time
Diversity makes us stronger! That is why we explicitly encourage people of all identities, lifestyles, and backgrounds to apply.
B. Braun SE | Haakon Schröder |