Quality Systems Auditor: Audits & Inspections Coordination

7555-Janssen Pharmaceutica NV Legal Entity; Geel; Sur place; EUR 55 000 - 75 000; Plein temps

Avantages offerts par ce poste

Team environment

Growth opportunities

Inclusive workplace

Competitive compensation

Impact on patient outcomes

Résumé du poste

Johnson & Johnson is seeking a detail-oriented Associate, CSQ Quality Systems – Audits & Inspections to join the Clinical Supply Quality team. You will support planning, coordination, and execution of internal and external audits across Beerse, Leiden, and ECSQ, ensuring timely scheduling and CAPA follow-up.

The role requires strong GxP knowledge, audit management, and cross-site collaboration, with Dutch and English proficiency as essential assets.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or related field; advanced degree preferred.
• Minimum 2–4 years in quality assurance, quality systems, or audits within a regulated environment.
• Strong knowledge of GxP regulations, ICH guidelines, and health authority inspection expectations.
• Experience with audit planning, execution, and inspection readiness; auditor certification a plus.
• Experience with electronic quality systems and data reporting tools (Power BI, Tableau).
• Dutch and English proficiency is a must; additional European languages are an asset.

Responsabilités

• Audit Planning & Coordination: support annual internal and external audit plans across CSQ.
• Internal Audits: support execution of internal audits and CAPA tracking.
• External Audits: coordinate external audits of suppliers and service providers.
• Inspection Readiness: assist in preparing for health authority inspections across sites.
• Inspection Support: provide logistical and documentation support during inspections.
• CAPA & Follow-up: monitor findings and ensure timely responses and corrective actions.
• Metrics & Reporting: track KPIs and provide CSQ leadership with insights.
• Documentation & Compliance: maintain audit-ready records per GxP and ALCOA+ standards.

Connaissances

GxP knowledge

Auditing

Cross-site coordination

Analytical skills

Communication skills

Formation

Bachelor's degree in Life Sciences

Advanced degree preferred

Outils

COMET

Veeva

TruVault

SUMMIT

Power BI

Tableau

Description du poste

Johnson & Johnson is seeking a detail-oriented Associate, CSQ Quality Systems – Audits & Inspections to join the Clinical Supply Quality team. You will support planning, coordination, and execution of internal and external audits across Beerse, Leiden, and ECSQ, ensuring timely scheduling and CAPA follow-up.

The role requires strong GxP knowledge, audit management, and cross-site collaboration, with Dutch and English proficiency as essential assets.