Senior Auditor Quality Assurance Manager (m / f / x)

Senior Auditor Quality Assurance Manager (m / f / x) || Hessen || Medical Devices

Responsibilities :

• Lead audits for clinical trials and medical products to ensure compliance with GxP and regulatory standards.
• Develop and implement audit plans based on risk assessments and conduct internal process and vendor audits.
• Address and escalate serious clinical trial violations, ensuring timely resolution.
• Contribute to the development and maintenance of the Quality Management System (QMS), focusing on document management, CAPA, deviations, and SOPs.
• Advise the Clinical Operations team on CAPA management and quality-related issues.
• Provide independent consultation on GCP-related and quality issues within clinical research.
• Support the qualification process for clinical development suppliers and lead supplier audits.
• Train employees on best practices in GCP, GCLP, pharmacovigilance, and clinical trial regulations.
• Coordinate inspections and audits by regulatory authorities and ensure readiness for external audits.
• Manage CAPA actions from inspections and support regulatory compliance within R&D

Requirements :

• Master’s degree in Natural Sciences, Pharmacy, Medicine, or a related field.
• At least 8 years of experience as a QA Auditor, preferably in clinical research or the medical device industry.
• Strong knowledge of GxP guidelines, clinical trial processes, and relevant regulatory standards.
• Experience conducting audits, inspections, and managing compliance.
• Excellent analytical skills, with the ability to assess complex data and identify risks and trends.
• Independent, organized, and able to work effectively with cross-functional teams.
• Strong communication skills and the ability to collaborate internationally.
• Willingness to travel (approx. 20% of the time).
• Fluency in English; German is a plus.

About the Client :

This company offers a great working environment with a global perspective and the opportunity to work in an international team. The flexible hybrid model allows you to work 2 days in the office and 3 days remotely. With an average employee tenure of over 8 years, the company provides long-term stability and growth opportunities. In addition to a competitive salary, employees enjoy attractive benefits such as Wellpass, Jobticket, Jobbike, 39 vacation days, a pension plan, and childcare support.

If you\’re passionate about driving clinical trials forward in the field of medical devices, with a strong emphasis on cross-functional leadership, efficiency, and quality compliance, we encourage you to apply.

I´m looking forward to seeing your application!

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