Quality Manager (CSV)

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

Benefits offered by this job

Hybrid working model

Meal allowance

Private health insurance

Company-funded training

Annual leave 23 days

Live and accident insurance

Job summary

B. Braun Medical, S.A. in Barcelona is seeking a Quality Manager to lead computerized system validation activities within Group Digital Department (GDD). The role focuses on developing robust CV processes, risk-based validation, and ensuring compliance with GAMP 5 and internal standards.

The ideal candidate has a degree in a related field, CSV experience, and strong English communication. The position offers hybrid work and a comprehensive benefits package in a dynamic tech hub.

Qualifications

• Experience in Computerized System Validation (CSV) and quality procedures.
• Knowledge of GAMP 5 principles and risk-based qualification approaches.
• Exposure to cloud-based services and software development processes.
• Strong written and verbal English communication skills.

Responsibilities

• Develop, maintain, and improve qualification and validation processes for computerized systems per GAMP 5 and internal requirements.
• Support risk-based qualification and validation activities for systems including cloud services and web apps.
• Create, review, and maintain qualification and validation documentation (plans, RISKS, requirements, test docs, traces, reports).
• Ensure CV/validation requirements are integrated into system development, implementation, operation and change management.

Skills

CSV experience

GAMP 5

Risk-based validation

Cloud services knowledge

Software quality assurance

English communication

Attention to detail

Delivery-focused

Continuous learner

Education

Degree in Computer Science or Engineering or IT or Quality Management

Job description

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

What We Offer

Gross annual salary starting from €50,000, depending on the candidate’s profile and experience.

To Help You Perform At Your Best, Our Offer Focuses On Your Wellbeing, Development And Experience As Part Of The Team

• 10% variable bonus based on global and spanish company results
• Hybrid working model: 3 days working from home and 2 days in the office
• Modern, newly designed offices in central Barcelona, located on Tuset Street, next to Diagonal, in a vibrant and international Tech Hub environment
• Flexible schedule: start from 7:00 to 9:30, finish from 16:00 to 18:30
• Intensive working hours on Fridays
• Flexible compensation: transport, childcare and private health insurance
• Company-funded training and certifications based on individual and business needs
• Meal allowance and home-working allowance
• Free wellbeing platform including coaching, psychological consultations and emotional health content, with the option to extend access to family members at a discounted rate
• 23 calendar days of annual leave
• Life and accident insurance
• Benefits under the Chemical Industry Collective Agreement

Diversity makes us stronger! That is why we explicitly encourage people of all identities, lifestyles, and backgrounds to apply.

B. Braun Medical, S.A. U. | Aitana Altuna