Global IM CSV Quality Lead: Validation & Data Integrity

Johnson Johnson; Beerse; Presencial; EUR 150.000 - 190.000; Jornada completa

Descripción de la vacante

Johnson & Johnson is seeking an IM CSV Quality Lead responsible for assessing, implementing, and improving the IM validation strategy, ensuring systems are validated and compliant with EU GMP Annex 11 and FDA 21 CFR Part 11.

This role leads a global network of CSV leads, drives lifecycle validation, risk-based approaches, data integrity, and the adoption of modern validation practices across IM.

It may be based at listed locations or another J&J IM Supply Chain site.

Responsabilidades

• Acting as IM Quality single point of contact for CSV.
• IM CSV Strategy & Governance Onboards and supports the J&J enterprise CSV framework in IM aligned with regulatory expectations and internal quality systems
• Deploys standards for lifecycle validation, risk-based approaches, and system classification across IM
• Define and monitor KPIs for validation effectiveness and compliance.
• Data Integrity & Compliance Ensure implementation of data integrity principles (ALCOA+) across all systems and processes

Descripción del empleo

Johnson & Johnson is seeking an IM CSV Quality Lead responsible for assessing, implementing, and improving the IM validation strategy, ensuring systems are validated and compliant with EU GMP Annex 11 and FDA 21 CFR Part 11.

This role leads a global network of CSV leads, drives lifecycle validation, risk-based approaches, data integrity, and the adoption of modern validation practices across IM.

It may be based at listed locations or another J&J IM Supply Chain site.