Lead Internal Auditor - Global Quality (m/f/d)

Your Qualifications:

• 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.

Your Tasks:

• 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.
  
• Secondary Responsibilities - Inspection Readiness & Notified Body Support
  
• 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

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