Lead Internal Auditor – Global Quality

Location: Germany, remote or site-based within the EU/UK; global travel of up to 50% required.

Pay range: €51,240–€80,063 per annum in Italy.

Company

hirify.global’s Global Quality Organization supports quality and regulatory compliance in pharmaceutical and medical device environments.

What you will do

• Plan, lead, and conduct risk-based internal audits across pharmaceutical and medical device operations.
• Serve as lead auditor for complex, cross-functional, and multi-site audits, covering planning, execution, reporting, and follow-up.
• Assess Quality Management System compliance and effectiveness against ISO 9001, ISO 13485, FDA cGMP/QSR, EU GMP, IVDR, and ICH requirements.
• Develop audit strategies and reports, communicate findings and trends, and identify systemic issues.
• Drive continuous improvement initiatives and provide guidance on regulatory and quality requirements while maintaining auditor independence.
• Support inspection readiness, regulatory authority inspections, Notified Body audits, and responses to nonconformities.

Requirements

• Bachelor’s degree in science, engineering, or a related field; an advanced degree is preferred.
• 8+ years of experience in regulated quality systems, internal auditing, or regulatory compliance within pharmaceutical and/or medical device industries.
• 5+ years of experience as a lead internal auditor, including audit planning, execution, and auditor management.
• ISO 13485 Lead Auditor certification is required.
• Experience auditing the full product lifecycle, including design, manufacturing, laboratories, post-market surveillance, and support processes.
• Strong analytical, risk-based thinking, problem-solving, communication, and stakeholder-influencing skills in global matrix organizations.

Culture & Benefits

• Option to work remotely or from a site within the EU/UK.
• Full-time daytime schedule with no stated end date.
• Work involves collaboration with Quality, Regulatory, and site leadership teams.
• Travel required up to 50% of the time.