Global Lead Internal Auditor – QMS & Regulatory (Remote)

Agilent Technologies; Italia; In loco; EUR 51.000 - 80.000; Tempo pieno

Descrizione del lavoro

Agilent Technologies in Italy is seeking a Lead Internal Auditor to plan, lead, and execute risk-based audits across regulated medical devices and pharmaceutical environments. You will act as a subject matter expert in quality systems and regulatory auditing, driving continuous improvement of the QMS within the Global Quality Organization.

The role focuses on the regulated internal audit program, with secondary support for inspection readiness activities.

Competenze

• Bachelor’s degree in science, engineering, or related field required; advanced degree preferred.
• 8+ years’ experience in regulated quality systems, internal auditing, or regulatory compliance within pharmaceutical and/or medical device industries.
• 5+ years’ experience as a Lead Internal Auditor, including audit planning, execution, and auditor management; ISO 13485 Lead Auditor certification required.
• Experience auditing across the full product lifecycle, including design, manufacturing, laboratories, post-market surveillance, and support processes.
• Strong analytical, risk-based thinking, problem-solving, and communication skills, with the ability to influence across global matrix organizations.
• Proven ability to manage multiple audits and priorities while maintaining professionalism, integrity, and sound judgment.
• Willingness to travel globally up to 50%; role may be remote or site-based within the EU/UK.

Mansioni

• 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.

Conoscenze

Analytical thinking

Risk-based thinking

Problem solving

Communication

Formazione

Bachelor’s degree in science/engineering

Advanced degree preferred

Strumenti

ISO 13485 Lead Auditor certification

Descrizione del lavoro

Agilent Technologies in Italy is seeking a Lead Internal Auditor to plan, lead, and execute risk-based audits across regulated medical devices and pharmaceutical environments. You will act as a subject matter expert in quality systems and regulatory auditing, driving continuous improvement of the QMS within the Global Quality Organization.

The role focuses on the regulated internal audit program, with secondary support for inspection readiness activities.