Quality Manager (CSV) | Cloud Validation Lead, Hybrid

B. Braun; Barcelona; Hybrid; EUR 45,000 - 55,000; Full time

Benefits offered by this job

Hybrid working model

Meal allowance

Private health insurance

Life and accident insurance

Annual leave 23 days

Job summary

B. Braun in Barcelona is seeking a Quality Manager (CSV) to support computerized system validation activities across the GDD. You will develop processes, templates, and guidance in line with GAMP 5 and internal requirements.

The role demands hands-on experience in CSV, cloud-based services, and software development processes, plus strong English communications. You will collaborate across functions, deliver training, and help ensure quality and compliance.

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.

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.

Skills

CSV experience

GAMP 5

Cloud-based services

Documentation quality

English proficiency

Education

Degree in Computer Science/Engineering/IT/Quality Management

Job description

B. Braun in Barcelona is seeking a Quality Manager (CSV) to support computerized system validation activities across the GDD. You will develop processes, templates, and guidance in line with GAMP 5 and internal requirements.

The role demands hands-on experience in CSV, cloud-based services, and software development processes, plus strong English communications. You will collaborate across functions, deliver training, and help ensure quality and compliance.