Lead Internal Auditor – Global Quality

About the role

The Lead Internal Auditor within the Customer Quality & Compliance team will plan, lead and execute risk‑based internal audits across regulated pharmaceutical and medical‑device operations. Acting as a subject‑matter expert, the role ensures compliance with global regulations and drives continuous improvement of the Quality Management System.

Key responsibilities

• Lead and conduct risk‑based internal audits across pharmaceutical and medical device operations in line with the approved audit schedule.
• Serve as Lead Auditor for complex, cross‑functional and multi‑site audits, managing planning, execution, reporting and follow‑up.
• Assess QMS compliance against ISO 9001, ISO 13485, FDA cGMP/QSR, EU GMP, IVDR and ICH requirements.
• Identify systemic issues, communicate findings and drive continuous improvement initiatives.
• Support inspection and audit readiness activities, preparing documentation for regulatory authorities and Notified Body audits.
• Train and coach sites on self‑directed audits and ensure auditor independence.

Required profile

• Bachelor’s degree in science, engineering or related field (advanced degree preferred).
• 8+ years experience in regulated quality systems, internal auditing or regulatory compliance within pharma/medical‑device industries.
• 5+ years experience as a Lead Internal Auditor with ISO 13485 Lead Auditor certification.
• Proven ability to manage multiple audits, influence global matrix organisations and travel up to 50% globally.

Required skills

• ISO 13485 Lead Auditor certification.
• Knowledge of ISO 9001, ISO 13485, FDA cGMP/QSR, EU GMP, IVDR and ICH standards.
• Risk‑based audit planning and execution.
• Strong analytical and problem‑solving abilities.