Global GMP Senior Quality Auditor

About the role

As a Global GMP Senior Quality Auditor you will lead independent GMP audits across Novartis sites and partners, ensuring compliance with current regulations and internal quality standards. The role involves extensive travel (up to 60%) and can be based in Madrid, Barcelona or Ljubljana.

Key responsibilities

• Develop and support a risk‑based global audit strategy aligned with corporate objectives.
• Plan, conduct, document and follow‑up on complex GMP audits, including sterile API, aseptic DP and combination products.
• Prepare audit reports, review corrective action plans (CAPA) and ensure timely remediation.
• Provide technical guidance, mentoring and training to junior auditors.
• Act as a GMP compliance consultant for trainings, task forces and continuous‑improvement projects.
• Escalate critical findings to management and track mitigation plans.

Required profile

• 12+ years of experience in the pharmaceutical or medical‑device industry.
• Strong knowledge of GMP regulations and practical judgement in their application.
• Proven experience in conducting high‑risk GMP audits.
• Excellent analytical and communication skills.

Required skills

• GMP auditing
• Regulatory compliance
• CAPA management