Auditor Quality Assurance Manager (m / f / x)

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 :

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!

Contact details :

E-Mail : M.Inderhees@sciproglobal.de

Tel : 089 26 20 09 25