CSQ Quality Auditor: Audits & Inspections

Johnson & Johnson Innovative Medicine; Beerse; Sur place; EUR 60 000 - 85 000; Plein temps

Avantages offerts par ce poste

Competitive compensation

Career development

Inclusive workplace

Cross-site collaboration

Résumé du poste

Johnson & Johnson Innovative Medicine is seeking an Associate, CSQ Quality Systems – Audits & Inspections to join the Clinical Supply Quality team in Beerse. The role focuses on planning and coordinating internal and external audits and preparing for health authority inspections across CSQ sites.

You will support audit execution, CAPA tracking, and documentation reviews, ensuring readiness and compliance with GxP, ALCOA+ and J&J standards. Collaboration across Beerse and Leiden is essential.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering or related field.
• 2–4 years in quality assurance, quality systems, or audits in a regulated environment.
• Strong knowledge of GxP, ICH guidelines and health authority expectations.
• Experience with electronic quality systems and data reporting tools.

Responsabilités

• Audit planning and coordination across CSQ sites.
• Support internal (self-inspection) audits and CAPAs.
• Coordinate external audits of suppliers and service providers.
• Assist in inspection readiness and documentation reviews.
• Provide support during health authority inspections and tracking actions.
• Monitor audit findings and ensure timely closure of CAPAs.
• Track KPIs and report status to CSQ leadership.

Connaissances

Audit planning

Cross-site coordination

Communication

English proficiency

Formation

Bachelor’s degree in Life Sciences, Pharmacy, Engineering

Outils

COMET

Veeva

TruVault

SUMMIT

Power BI

Tableau

Quickbase

Description du poste

Johnson & Johnson Innovative Medicine is seeking an Associate, CSQ Quality Systems – Audits & Inspections to join the Clinical Supply Quality team in Beerse. The role focuses on planning and coordinating internal and external audits and preparing for health authority inspections across CSQ sites.

You will support audit execution, CAPA tracking, and documentation reviews, ensuring readiness and compliance with GxP, ALCOA+ and J&J standards. Collaboration across Beerse and Leiden is essential.