Global IM CSV Quality Lead: Validation & Data Integrity

Johnson & Johnson Innovative Medicine; Oost-Vlaanderen; On-site; EUR 96,000 - 165,000; Full time

Job summary

Johnson & Johnson Innovative Medicine is seeking an IM CSV Quality Lead to define validation strategy for computer systems and embedded AI in a GxP setting. You will ensure validation, lifecycle maintenance, and compliance with EU Annex 11 and FDA 21 CFR Part 11 across IM systems.

You will lead a global network of CSV leads, drive risk-based validation, data integrity, and QRM, and mentor teams while advancing modernization of validation approaches and AI governance.

Qualifications

• University/Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field.
• 10+ years of combined experience in Manufacturing, Quality Assurance, Quality Control in vaccines/pharmaceutical industry.
• Extensive CSV experience in a GxP-regulated environment.
• Proven knowledge of Data Integrity regulations (Annex 11 / 21 CFR Part 11).
• Leadership experience in global or cross-site roles.

Responsibilities

• Act as IM CSV single point of contact for CSV and compliance issues; communicate with senior stakeholders.
• Onboards and supports the CSV framework for IM; deploys lifecycle validation standards and risk-based approaches.
• Oversee validation activities across system lifecycle (planning→ design→ testing→ release→ maintenance).
• Define and monitor KPIs for validation effectiveness and compliance.
• Ensure data integrity (ALCOA+) across all systems and processes.
• Lead a global network of CSV leads; provide training and mentorship.

Skills

CSV in GxP

Quality systems

Risk management

Project management

Communication skills

Global / cross-site leadership

Education

Bachelor’s degree in Life Sciences or related

Master’s degree preferred

Job description

Johnson & Johnson Innovative Medicine is seeking an IM CSV Quality Lead to define validation strategy for computer systems and embedded AI in a GxP setting. You will ensure validation, lifecycle maintenance, and compliance with EU Annex 11 and FDA 21 CFR Part 11 across IM systems.

You will lead a global network of CSV leads, drive risk-based validation, data integrity, and QRM, and mentor teams while advancing modernization of validation approaches and AI governance.