Lead Internal Auditor – Global Quality

This is a fully remote position, open to applicants in Germany.

📋 Description

• Lead and conduct risk-oriented internal audits across pharmaceutical and medical device operations in accordance with the sanctioned audit schedule.

• Act as the Lead Auditor for intricate, cross-functional, and multi-site audits, managing planning, execution, reporting, and follow-up activities.

• Evaluate QMS compliance and effectiveness against ISO 9001, ISO 13485, FDA cGMP/QSR, EU GMP, IVDR, and ICH standards.

• Formulate audit strategies, plans, and reports, conveying findings, trends, and opportunities for improvement to stakeholders.

• Detect systemic issues and promote continuous improvement initiatives within the QMS.

• Offer guidance on the interpretation and implementation of regulatory and quality standards while ensuring auditor independence.

• Educate and mentor sites on self-directed audits to bolster the Internal Audit Program with necessary oversight.

• Assist in inspection and audit readiness efforts to sustain a state of ‘Always Audit Ready’.

• Aid in preparations for regulatory authority inspections and Notified Body audits, encompassing readiness reviews and documentation preparation.

• Support responses to nonconformities and observations as necessary.

⛳️ Requirements

• Bachelor’s degree in science, engineering, or a related discipline is mandatory; an advanced degree is preferred.

• Over 8 years of experience in regulated quality systems, internal auditing, or regulatory compliance within the pharmaceutical and/or medical device sectors.

• A minimum of 5 years of experience as a Lead Internal Auditor, which includes audit planning, execution, and auditor management; ISO 13485 Lead Auditor certification is essential.

• Experience in auditing throughout the complete product lifecycle, including design, manufacturing, laboratories, post-market surveillance, and support processes.

• Excellent analytical, risk-based thinking, problem-solving, and communication abilities, with the capacity to influence within global matrix organizations.

• Demonstrated ability to manage multiple audits and priorities while upholding professionalism, integrity, and sound judgment.

• Willingness to travel internationally up to 50% of the time.

🏝️ Benefits

• Option to work remotely from various EU countries.

• Paid time off.

• Opportunities for professional development.