Quality Management Specialist (m/f/d)

Overview

Allogenetics GmbH is a spin-off of the Hannover Medical School and a rapidly growing biotech start-up based in Hannover. Together, we are shaping the future of transplantation medicine by developing therapies that prevent organ rejection after transplantation. This work has a meaningful impact on patients worldwide.

As part of our team, you will work on a project that combines medical innovation with significant societal impact. We operate in a dynamic environment characterised by flat hierarchies, interdisciplinary collaboration and an open, appreciative culture.

To support our team, we are looking for a Quality Management Specialist (m/f/d) to join us as soon as possible.

Tasks

Your Key Tasks

You ensure the implementation and continuous improvement of a GxP-compliant Quality Management System and maintain compliance with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) standards. In this role, you support clinical development activities, manage quality risks and CAPAs, and collaborate closely with cross-functional teams.

• Develop and implement a Quality Management System (QMS) aligned with GxP standards, ensuring compliance with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) throughout product and clinical development.
• Define quality objectives and establish a strategic quality program, including organizational policies and procedures.
• Develop and maintain comprehensive quality documentation , such as manuals, SOPs, and protocols.
• Identifying and assess quality risks , implementing effective mitigation strategies through robust risk management practices.
• Address quality issues , monitor and review corrective actions (deviation and CAPA management).
• Continuously improve processes to enhance product and service quality.
• Support sponsor responsibilities in clinical trials , ensuring adherence to regulatory and ethical standards.
• Plan and conduct internal and external audits and inspections to verify compliance with applicable regulations and guidelines.
• Provide training and support to staff on quality-related topics, fostering a culture of quality and compliance.
• Serve as the primary contact point for quality and compliance inquiries , offering expert advice and solutions.

Requirements