B. Braun Healthcare/BioTech

Quality Manager (f/m/d)

Melsungen, Germany Hybrid Full-time

Company

B. Braun SE

Job Posting Location

Melsungen, Hessen, Germany, Tuttlingen, Baden-Württemberg, Germany

Functional Area

Information Technology

Working Model

Hybrid

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 |

Job description provided by B. Braun.
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