Zum Inhalt springen
CBmed logo

Qualitätsmanagement / Qualitätssicherung Experte

CBmed · Forschung & Wissenschaft

Zusammenfassung

Diese Rolle beinhaltet die Steuerung der Implementierung von Good Clinical Practice (GCP)-Anforderungen innerhalb des Qualitätsmanagementsystems, die Identifizierung von Lücken, die Definition von Maßnahmen und die Entwicklung von GCP-konformen Verfahren und Schulungen. Die Position umfasst auch die Unterstützung bei Audits, die Pflege des Dokumentenmanagementsystems und die kontinuierliche Verbesserung des Qualitätsmanagementsystems.

Eckdaten

Status
Verfügbar
Standort
Österreich
Vertrag
Vollzeit
Arbeitszeit
40 Std./Woche
Arbeitsmodell
Hybrid
Startdatum
Ab sofort
Level
Erfahren
Sprachen (erforderlich)
  • DeutschVerhandlungssicher
  • EnglischVerhandlungssicher
Geforderte Kenntnisse
  • GCP
  • Qualitätsmanagement
  • Qualitätssicherung
  • GxP
  • ISO 9001
  • ISO 15189
  • IVDR
  • Microsoft Office
Benefits
  • Flexible Arbeitszeiten
  • Möglichkeit zum Homeoffice
  • Unbefristete Anstellung
  • Transparenter Gehaltsrahmen
Gehalt
€58k/yr

Vollständige Beschreibung

Quality Management / Quality Assurance Expert (all genders)

Austria’s leading company – CBmed is a center for biomarker research in medicine with headquarter in Graz. We bring together excellent research infrastructure, scientific expertise, medical knowledge, and national and international partners to advance biomarker research and precision medicine.

To strengthen our team, we are looking for a collaborative and quality-driven

Quality Management / Quality Assurance Expert (all genders) who would like to contribute their experience and further develop quality processes in an interdisciplinary research environment.

Your role

In this position, you will contribute to the further development of our quality management system, with a particular focus on Good Clinical Practice (GCP) and our role as a laboratory service provider for clinical studies.

Your responsibilities will include

  • Drive the implementation of GCP requirements within the quality management system
  • Identify GCP-related gaps, define implementation measures and coordinate their integration into laboratory processes and quality assurance activities
  • Develop and implement GCP-aligned procedures and training, and support their effective application in day-to-day operations
  • Assisting in the preparation and documentation of internal and external audits
  • Update and maintenance of the company wide document management system
  • Continuous improvement of company-wide quality management system
  • Assisting the TQM Manager in overall rollout of quality related tasks within the organization What you bring

Essential qualifications

  • Practical experience in quality management or quality assurance in a GxP-regulated environment
  • Good knowledge of GCP and an understanding of how regulatory requirements can be translated into practical quality processes
  • A scientific or technical qualification, or equivalent knowledge and skills gained through professional experience, further education or other career paths
  • Confidence in communicating quality requirements and the ability to support constructive change across the organisation
  • Ability to prioritise tasks and work in a structured, accurate and reliable manner
  • A structured and reliable approach to work
  • Good communication and collaboration skills
  • Professional working proficiency in German and English Additional qualifications that are welcome, but not essential
  • Hands-on experience in implementing GCP requirements within an organization
  • Knowledge of ISO 9001, ISO 15189 or IVDR
  • Experience in project management
  • Familiarity with Microsoft 365 applications What we offer:
  • Meaningful work contributing the development of precision medicine
  • The opportunity to shape and continuously improve our quality management system
  • A varied role across GCP, audits, quality assurance, training and process improvement
  • An international and interdisciplinary working environment
  • Continuous learning and professional development
  • Flexible working hours and the possibility of working from home
  • A family-friendly, collaborative and supportive workplace
  • A permanent position with a transparent salary framework You will have the opportunity to work in an internationally connected company, within a committed, agile and motivated team.

We offer an unlimited contract with a yearly salary from € 58000 gross based on 40 hours/week. Overpayment is possible, depending on qualifications and work experience. Applications are welcomed on an ongoing basis.

Diversity strengthens our work. At CBmed, we value different perspectives, experiences and backgrounds. We welcome applications regardless of age, gender, gender identity, sexual orientation, disability, ethnic or social background, religion, belief or family responsibilities.

If you are interested in the position but do not meet every listed qualification, we still encourage you to apply. Skills and experience can be gained through many different professional and personal pathways.

If you require any adjustments or support during the application process, please contact us at career@cbmed.at. We will be happy to assist you.

CBmed GmbH CENTER FOR BIOMARKER RESEARCH IN MEDICINE Stefanie Michaela Jandrisits, MA (career@cbmed.at)

+43 316 385 28808 Stiftingtalstrasse 14 8010 Graz

Apply here

Beim Unternehmen bewerben