Quality Manager (CSV)

B. Braun (Switzerland) · Barcelona, Spain

About the role

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

Join us and let's drive advancements in healthcare! Apply now!

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