Lead Internal Auditor – Global Quality

Agilent Technologies

Lead Internal Auditor responsible for risk-based internal audits in pharmaceutical and medical device sectors. Ensures compliance with global regulations and drives quality management improvements.

Posted 5/27/2026full-timeRemote • 🇩🇪 GermanySeniorWebsite

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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%

Benefits

Comp & perks

Option to work remotely in various EU countries
Paid time off
Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

internal auditingQMS complianceaudit planningaudit executionregulatory compliancerisk-based thinkingproblem-solvingISO 9001ISO 13485FDA cGMP/QSR

Soft Skills

analytical skillscommunication skillsinfluencing skillsprofessionalismintegritysound judgmentcoachingtrainingcontinuous improvementstakeholder communication

Certifications

ISO 13485 Lead Auditor certification