Quality Management Specialist (mfd)

Allogenetics GmbH; Hannover; Hybrid; EUR 45.000 - 65.000; Vollzeit

Zusammenfassung

A dynamic biotech startup in Hannover is looking for a Quality Management Specialist to join their team. This role involves ensuring compliance with regulatory standards, developing a GxP-compliant Quality Management System, and supporting clinical development activities. The ideal candidate should have a degree in life sciences, experience with Quality Management Systems, and excellent communication skills in both English and German. The position offers competitive compensation and flexible work arrangements, contributing to meaningful innovations in transplantation medicine.

Leistungen

Competitive compensation

Flexible working hours

Opportunities for professional development

Qualifikationen

• Experience with Quality Management Systems (QMS) in complex environments.
• Knowledge of quality standards and regulatory requirements.
• Strong attention to detail and organizational skills.
• Effective problem-solving and teamwork abilities.
• Excellent communication skills in English and German.

Aufgaben

• Ensure implementation of a GxP-compliant Quality Management System.
• Develop and maintain comprehensive quality documentation.
• Conduct internal and external audits.
• Provide training and support on quality-related topics.

Kenntnisse

Quality Assurance

FDA Regulations

Data Collection

Food Safety Experience

ISO 9001

Mobile Devices

Root Cause Analysis

Quality Systems

OSHA

Food Processing

Quality Management

cGMP

Ausbildung

Degree in life sciences or related field

Jobbeschreibung

Quality Management Specialist (m/f/d) Allogenetics GmbH•Hanover, Lower Saxony, Germany

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). 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 GMP and GCP throughout product and clinical development.
• Define quality objectives and establish a strategic quality program including organisational policies and procedures.
• Develop and maintain comprehensive quality documentation such as manuals, SOPs and protocols.
• Identify 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

Your Profile

• Degree in life sciences or related field (or equivalent professional experience).
• Experience with Quality Management Systems (QMS) and process development in complex environments (e.g. clinical trials).
• Knowledge of quality standards and regulatory requirements (e.g. ICH GCP EU GMP).
• Strong attention to detail, organisational and project management skills.
• Effective problem‑solving and teamwork abilities.
• Excellent communication skills in English and German.
• High sense of responsibility and reliability.

Benefits

What we offer:

• A meaningful role that contributes directly to innovations in transplantation medicine.
• Competitive compensation and flexible working hours including the option to work partially remotely.
• Hands‑on experience in a dynamic biotech environment where you can contribute ideas and take ownership of your work.
• Varied and challenging tasks with room for professional creativity and initiative.
• An international perspective in a cutting‑edge field of medical innovation.
• Long‑term development opportunities and career growth within the company.

Transparency matters to us.

As a young biotech start‑up we are gradually expanding our benefits package particularly with regard to professional development and work‑life balance.

Equal opportunities

Allogenetics is committed to diversity and equal opportunities. We expressly encourage applications from women. Candidates with disabilities will be given preferential consideration if equally qualified.

Make your talent count where it really matters!

At Allogenetics we are working to improve the lives of transplant patients by delivering genuine medical innovation with meaningful societal impact. If you want to contribute and help shape the future we look forward to receiving your application. Together we create solutions that save lives and redefine the future of medicine.

Interested

We look forward to receiving your application here or via email at . We are hiring as soon as possible and have designed our application process to be quick and simple so you will receive feedback promptly.

Key Skills
Quality Assurance,FDA Regulations,Data Collection,Food Safety Experience,ISO 9001,Mobile Devices,Root cause Analysis,Quality Systems,OSHA,Food Processing,Quality Management,cGMP
Employment Type : Employee
Experience: years
Vacancy: 1