Quality Systems Lead: Data Integrity & Validation

Johnson Johnson; Leiden; In loco; EUR 110.000 - 160.000; Tempo pieno

Descrizione del lavoro

Johnson & Johnson in Leiden, Netherlands seeks a Manager Quality Systems Data Integrity & Validation to lead Data Integrity, Validation and computerized systems compliance within BioTherapeutics Quality Systems and Compliance. The role requires strong judgment to translate regulatory expectations into practical Quality System requirements and drive improvements with cross-functional teams.

The position focuses on data governance, validation lifecycle management, and digital transformation in a

Competenze

• Experience in Data Integrity, Validation and computerized systems compliance.
• Ability to interpret regulatory expectations into Quality System requirements.
• Experience in a complex GxP environment with inspection readiness.

Mansioni

• Oversee Data Integrity program and governance.
• Lead Data Integrity risk assessments, audits, remediation.
• Provide validation oversight for GxP computerized systems.
• Ensure lifecycle validation documents are compliant and up to date.
• Partner with cross-functional teams to implement improvements.

Conoscenze

Quality Oversight

Data Integrity

Validation

GxP Compliance

Regulatory Knowledge

Cross-functional Collaboration

Descrizione del lavoro

Johnson & Johnson in Leiden, Netherlands seeks a Manager Quality Systems Data Integrity & Validation to lead Data Integrity, Validation and computerized systems compliance within BioTherapeutics Quality Systems and Compliance. The role requires strong judgment to translate regulatory expectations into practical Quality System requirements and drive improvements with cross-functional teams.

The position focuses on data governance, validation lifecycle management, and digital transformation in a