Lead Internal Auditor – Global Quality M/F/D

Job Description

Role Overview

The Lead Internal Auditor within the Customer Quality & Compliance team is responsible for planning, leading, and executing risk‑based internal audits within regulated medical devices and pharmaceutical environments. This role serves as a subject matter expert in quality system and regulatory auditing, ensuring compliance with applicable global regulations and standards while driving continuous improvement of the Quality Management System (QMS). This individual will be part of the broader Global Quality Organization.

The primary focus of the role is the regulated internal audit program. In addition, the role provides secondary support for inspection readiness activities, working in close collaboration with Quality, Regulatory, and site leadership teams.

Primary Responsibilities – Lead Internal Audit

• 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

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.

Additional Details

Travel Required:

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