GxP System Lead

Jobs2Web; Sant Cugat del Vallès; On-site; EUR 70,000 - 110,000; Full time

Job summary

Boehringer Ingelheim is seeking a GxP System Lead to own AMPLIFY within Clinical & RIM Vaults, ensuring regulatory compliance, validation and ongoing system readiness. You will collaborate with QA, CSV and IT teams to maintain a secure, reliable system and support regulatory inspections.

The role requires 3–5 years in a regulated environment, strong GxP/CSV knowledge and proficiency with JIRA, Kubernetes/OpenShift, Docker and Helm. Excellent English communication is essential.

Qualifications

• Bachelor’s or Master’s degree in Computer Science, Engineering or related field.
• 3–5 years of experience as system lead in pharma/regulated environments.
• Strong knowledge of GxP, CSV, data integrity and regulatory frameworks.
• Experience with JIRA, Kubernetes/OpenShift, Docker and Helm (EDP preferred).
• Experience with Veeva Medicine development solutions is desirable.
• Strong governance, risk management and quality processes.

Responsibilities

• Own the system’s purpose, scope and strategic direction.
• Act as primary accountable for performance, compliance and risk.
• Define and maintain system documentation, policies and usage guidelines.
• Oversee validation activities with QA and CSV teams; approve deliverables and changes.
• Ensure compliance with LEVA framework and GxP systems.
• Approve audits, security assessments and remediation activities.
• Approve system changes, upgrades, patches and integrations.
• Collaborate with IT teams, admins and vendors for stable operations.
• Monitor performance, service levels and incident resolution.
• Ensure the system is inspection-ready for audits.
• Support regulatory inspections with system documentation.

Skills

GxP knowledge

CSV expertise

Regulatory frameworks

Data integrity

Communication skills

Analytical thinking

Cross-functional collaboration

Education

Bachelor’s/Master’s in CS/Engineering

Tools

JIRA

Kubernetes

OpenShift

Docker

Helm

EDP

Job description

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