Lead Internal Auditor – Global Quality

🕒 May 27

🇩🇪 Germany – Remote

💵 €51.2k - €80.1k / year

⏰ Full Time

🟠 Senior

🔎 Auditor

👻 Ghost score 39%

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Agilent Technologies

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1999

🍽️ Food & Beverage

🏥 Healthcare

💼 Consulting

💰 $500M Post-IPO Debt on 2019-09

Food & Beverage • Healthcare • Consulting

Agilent Technologies is a global leader in the field of analytical and laboratory instruments. The company offers a diverse range of products and solutions, including gas and liquid chromatography, mass spectrometry, lab supplies, and software and informatics. Agilent serves various industries, such as biopharma, food and beverage testing, clinical diagnostics, and environmental testing. Additionally, Agilent provides comprehensive services for lab management, maintenance, and instrument repair. They focus heavily on advancing science through sustainable solutions and supporting genomics, pathology, and cancer research with advanced technologies.

📋 Description

• Plan, lead, and execute risk-based internal audits within regulated pharmaceutical and medical device operations • Serve as Lead Auditor for complex, cross-functional, and multi-site audits • Oversee audit 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 • Communicate findings, trends, and improvement opportunities to stakeholders • Identify systemic issues and drive continuous improvement initiatives across the QMS • Provide guidance on regulatory and quality requirements while maintaining auditor independence • Train and coach sites on self-directed audits • Support inspection and audit readiness activities • Assist with regulatory authority inspections and Notified Body audits, including readiness reviews and documentation preparation • Support responses to nonconformities and observations as required • Collaborate with Quality, Regulatory, and site leadership teams

🎯 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 • Ability to influence across global matrix organizations • 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

🏖️ Benefits

• Option to work remotely • Full-time weekly schedule • Opportunity to work remotely or site-based within the EU/UK