GxP System Lead

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. We are seeking a skilled and motivated GxP System Lead. In this role, you will hold overall accountability for AMPLIFY within Clinical & RIM Vaults. Ensuring the system meets business needs, complies with policies and regulations, and remains secure, reliable, and properly maintained. 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.

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. Strong skills working with JIRA, Kubernetes / OpenShift and its eco system (Docker, Helm), preferably with EDP. Experience with Veeva Medicine development solutions is desirable. 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.

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! Inscribirse en esta oferta Recibir ofertas similares por correo electrónico Al crear una alerta, aceptas nuestros Términos y condiciones y Política de privacidad, y el uso de cookies.