GxP Systems Lead — Compliance, Validation & Audit-Ready

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

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.