09 oct
|
Jobs2Web
|
San Cugat del Vallés
09 oct
Jobs2Web
San Cugat del Vallés
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 general 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 doc
📌 GxP System Lead (San Cugat del Vallés)
🏢 Jobs2Web
📍 San Cugat del Vallés