Medanex is a fast growing company and continuously looking for talent. Please let us know if you’re interested to join our team!
Quality Assurance Manager Preclinical Medical Device Studies
About Medanex Clinic:
Medanex Clinic is a global leader in surgical preclinical research in large animals for human applications. As CRO, we provide services, expertise and facilities to international R&D companies and universities for research, development and training on innovative human medical devices & therapies. Our capabilities are unique and appreciated by our clients worldwide. Compliance with the highest international quality standards is crucial in our work and therefore Medanex Clinic is fully GLP-accredited.
To support our growing activities, we are looking for an in-house Quality Assurance Manger to maintain and expand our GLP activities, together with our skilled team of study directors, veterinarians, scientists, biotechnicians and animal caretakers. The QA manager will have a leading role in all quality-related matters, supported by external consultants if needed.
Medanex Clinic provides, as SME, a supportive working environment in which the QA Manager can deploy his or her entrepreneurial and leadership capacities.
An experienced QA manager who wants to step into cutting-edge preclinical animal research for human applications, eager to learn, passionate about medical research and development.
Your responsibilities will be:
- Maintain, manage and improve the current GLP status of Medanex Clinic as Test Facility
- Perform internal audits of the facility and GLP studies
- Coordinate external audits from the GLP Monitorate, FDA, notified bodies and customers
- Implement and expand the GLP principles in new processes
- Advise clients on quality-related aspects of their studies
- Stay up-to-date with international medical device regulations
- Share your knowledge and insights; take opportunities for process improvement and implementation of new guidelines in the workflows
- You hold an academic degree in medical, biomedical, veterinary, pharmaceutical sciences, bioengineering or equivalent education.
- You have preferably more than 5 years of experience in a quality-related role in pre-clinical research of medical devices.
- You preferably have experience in a CRO setting.
- Knowledge of regulatory affairs is an asset.
- You are communicatively skilled to face clients and to interact with a diverse audience, including animal caretakers, biotechnicians, experts and management.
- You are an entrepreneur, taking ownership. You have the ability to multi-task and maintain organization in a fast paced, rapidly changing environment.
- You have verbal and written communication proficiency in English; the ability to read, analyze, understand, discuss and interpret complex scientific and regulatory documents. You are able to effectively communicate scientific data and conclusions.
- MS Office has no secrets to you
- An innovative and inspiring job opportunity in the attractive Medanex Clinic facilities in Diest (Belgium), in daily contact with multinationals & start-ups.
- Opportunities for self-development, in a well-organized facility structure.
- A pleasant and diverse work environment with the entrepreneurial can-do attitude of an SME, providing warm welcomes and support.
- Competitive remuneration.