Global Quality Lead Internal Auditor — Remote + Travel

Agilent Technologies; Gent; Hybride; EUR 51 000 - 80 000; Plein temps

Résumé du poste

Agilent Technologies is seeking a Lead Internal Auditor to plan, lead, and execute risk-based internal audits in regulated medical devices and pharmaceutical environments. You will serve as a subject matter expert in quality system and regulatory auditing within the Global Quality Organization.

The role focuses on the regulated internal audit program and provides secondary support for inspection readiness activities, collaborating with Quality, Regulatory, and site leadership teams.

Qualifications

• 8+ years in regulated quality systems and auditing within pharma/medical devices.
• 5+ years leading internal audits including audit planning and auditor management.
• ISO 13485 Lead Auditor certification required.
• Experience across design, manufacturing, labs, post-market.
• Willingness to travel up to 50%.
• Remote or site-based within the EU/UK.

Responsabilités

• 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, overseeing planning, execution, reporting, and follow-up.
• Assess QMS compliance and effectiveness against ISO 9001, ISO 13485, FDA cGMP/QSR, EU GMP, IVDR, and ICH requirements. Develop audit strategies, plans, and reports, communicating findings, trends, and improvement opportunities to stakeholders.
• Identify systemic issues and drive continuous improvement initiatives across the QMS.
• Provide guidance on the interpretation and application of regulatory and quality requirements while maintaining auditor independence.
• Train and coach sites on self‑directed audits to support the Internal Audit Program with appropriate oversight.
• Support inspection and audit readiness activities to maintain a state of ‘Always Audit Ready.’
• Assist with preparation for regulatory authority inspections and Notified Body audits, including readiness reviews and documentation preparation.
• Support responses to nonconformities/observations as required.

Connaissances

Lead Auditor experience

Regulatory auditing

Quality systems

Cross-functional teamwork

Risk assessment

Travel willingness

Formation

Bachelor’s degree in science/engineering

Advanced degree preferred

Outils

ISO 13485 Lead Auditor certification

Description du poste

Agilent Technologies is seeking a Lead Internal Auditor to plan, lead, and execute risk-based internal audits in regulated medical devices and pharmaceutical environments. You will serve as a subject matter expert in quality system and regulatory auditing within the Global Quality Organization.

The role focuses on the regulated internal audit program and provides secondary support for inspection readiness activities, collaborating with Quality, Regulatory, and site leadership teams.