Remote Lead Internal Auditor, Global Quality & Compliance

Agilent Technologies; Denmark; On-site; DKK 383,000 - 598,000; Full time

Job summary

Agilent Technologies seeks a Lead Internal Auditor to plan, lead, and execute risk-based audits across regulated medical devices and pharmaceutical environments. The role ensures compliance with global regulations and drives continuous improvement of the QMS within the Global Quality Organization.

The position focuses on an inspected-driven internal audit program and provides secondary support for inspection readiness and Notified Body activities across sites in the EU/UK.

Qualifications

• Bachelor’s degree in science, engineering, or related field.
• Advanced degree preferred.
• 8+ years’ experience in regulated quality systems, internal auditing, or regulatory compliance.
• 5+ years’ experience as a Lead Internal Auditor with ISO 13485 Lead Auditor certification.

Responsibilities

• Lead and conduct risk-based internal audits across pharmaceutical and medical device operations.
• Serve as Lead Auditor for complex, cross-functional, multi-site audits.
• Assess QMS compliance against ISO 9001, ISO 13485, FDA cGMP/QSR, EU GMP, IVDR, ICH.
• Identify systemic issues and drive QMS improvements.
• Provide regulatory guidance and maintain auditor independence.
• Train sites on self-directed audits.

Skills

Auditing

Quality systems

Regulatory compliance

Risk-based thinking

Communication

Auditor management

Education

Bachelor’s degree in science/engineering

Advanced degree preferred

Job description

Agilent Technologies seeks a Lead Internal Auditor to plan, lead, and execute risk-based audits across regulated medical devices and pharmaceutical environments. The role ensures compliance with global regulations and drives continuous improvement of the QMS within the Global Quality Organization.

The position focuses on an inspected-driven internal audit program and provides secondary support for inspection readiness and Notified Body activities across sites in the EU/UK.