Lead Internal Auditor (Quality Assurance, Remote/EU)

Job summary

The Lead Internal Auditor is responsible for planning, leading, and executing risk-based internal audits in regulated environments, specifically within the pharmaceutical and medical device sectors. This role emphasizes compliance with global regulations and the continuous improvement of the Quality Management System (QMS).

Qualifications

• Bachelor’s degree in science, engineering, or a related field; advanced degree preferred.
• Over 8 years of experience in regulated quality systems, internal auditing, or regulatory compliance in the pharmaceutical or medical device industries.
• At least 5 years as a Lead Internal Auditor, with ISO 13485 Lead Auditor certification required.
• Experience with auditing across the entire product lifecycle, including design, manufacturing, and post-market processes.
• Strong analytical and communication skills, with the ability to influence in a global matrix organization.
• Proven ability to manage multiple audits and priorities effectively.
• Willingness to travel globally up to 50%; position may be remote or site-based within the EU/UK.

Responsibilities

• Lead and conduct risk-based internal audits in accordance with the approved audit schedule.
• Serve as Lead Auditor for complex audits, overseeing all phases from planning to reporting.
• Assess compliance and effectiveness of QMS against various regulatory standards and develop audit strategies.
• Identify systemic issues and drive initiatives for continuous improvement in the QMS.
• Provide guidance on regulatory and quality requirements while maintaining auditor independence.
• Train and coach sites on self-directed audits to support the Internal Audit Program.
• Support inspection readiness activities and assist with regulatory authority inspections.

Skills

• Strong analytical and problem-solving skills.
• Effective communication and influencing skills across diverse teams.
• Ability to maintain professionalism and integrity in all audit activities.

Education

• Bachelor’s degree in a relevant field; advanced degree is a plus.

Tools

• Familiarity with ISO 9001, ISO 13485, FDA cGMP/QSR, EU GMP, IVDR, and ICH requirements.