Agilent Technologies logo
Agilent Technologies

Premier Laboratory Partner for a Better World

Lead Internal Auditor – Global Quality

AuditorAuditorFull TimeRemoteSeniorTeam 10,001+Since 1999H1B SponsorCompany SiteLinkedIn

Location

Germany

Posted

12 days ago

Salary

0

Seniority

Senior

Bachelor Degree8 yrs expEnglish

Job Description

Lead Internal Auditor – Global Quality

Agilent Technologies

• 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

Job Requirements

  • 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

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

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