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Gxp system lead

Barcelona
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.
Desplácese hacia abajo para encontrar una descripción detallada de este trabajo y lo que se espera de los candidatos. Envíe su solicitud haciendo clic en el botón "Solicitar".
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. xhfqzwm
Want to learn more? Visit J-18808-Ljbffr

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