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Gxp system lead

Vallés
Boehringer Ingelheim
Publicada el 22 abril
Descripción

At Boehringer Ingelheim, we believe that Data & AI have the power to transform healthcare and improve the lives of millions of patients and animals. As a key member of the IT Research Development and Medicine – Animal Health Global Innovation team, you will join a passionate group where you will meet and collaborate with like‐minded people dedicated to fostering a strong data and AI culture, delivering key transformation initiatives, and shaping the future of data‐driven decision‐making across our global organization. Your work will empower our researchers to achieve breakthrough therapies for patients.

Tasks And Responsibilities

Own the system's purpose, scope, and strategic direction, ensuring alignment with business objectives (Clinical & RIM)

Act as the primary accountable person for the system's performance, compliance, and risk posture

Define and maintain system documentation, including policies, procedures, and usage guidelines

Oversee validation activities in collaboration with QA and CSV teams, ensuring validated state is maintained. Approve validation deliverables, change controls, deviations, CAPAs, and periodic reviews

Ensure compliance with LEVA framework and GxP systems

Approve and oversee audits, security assessments, and remediation activities

Approve system changes, upgrades, patches, and integrations, ensuring continued compliance and validated status

Collaborate with IT teams, system administrators, and vendors to ensure stable operations

Monitor system performance, service levels, and incident resolution

Ensure the system is always inspection‐ready for internal and external audits

Support regulatory inspections, providing system documentation and subject‐matter expertise

Requirements

Bachelor's/Master's degree in Computer Science, Engineering, or related field or equivalent proven experience as a Data Engineer, Software Developer, or similar role

3 – 5 years of experience as system lead in pharmaceutical, biotech, or regulated manufacturing environments

Strong understanding of GxP, CSV, data integrity, and regulatory frameworks

Experience managing computerized systems in a validated environment

Strong skills working with Kubernetes / OpenShift and its ecosystem (Docker, Helm), preferably with EDP

Experience with Veeva Medicine development solutions

Strong knowledge of system governance, risk management, and quality processes

Ability to interpret and apply regulatory requirements to system operations

Excellent communication and cross‐functional collaboration skills

Analytical mindset with strong problem‐solving abilities

Excellent English written and verbal communication skills

#IamBoehringerIngelheim because...

We are continuously working to design the best experience for you. Here are some examples of how we will take care of you:

Flexible working conditions

Life and accident insurance

Health insurance at a competitive price

Investment in your learning and development

Gym membership discounts

If you have read this far, what are you waiting for to apply? We want to know more about you!

Our Company

Why Boehringer Ingelheim?With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Want to learn more? Visit https://www.Boehringer-ingelheim.Com

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