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.

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.


• 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.

#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!