Fujirebio is a leading player in the field of medical diagnostics. Driven by the passion and commitment of our employees, we deliver innovative healthcare solutions every day. Our high-quality products enable clinicians to make fast and accurate diagnoses in areas such as neurological disorders (including Alzheimer’s disease) and infectious diseases (such as Hepatitis C and HIV), ensuring that patients receive the right treatment in a timely manner.
Our diagnostic tests are developed and manufactured in Ghent and Tokyo, and are distributed to hospitals and laboratories worldwide. As part of the international H.U. Group—with colleagues across Asia, Europe and the United States—we are a close-knit global family. At our European headquarters in Ghent, around 185 employees work alongside approximately 50 colleagues in our European affiliates.
In search of a Compliance Officer
In taking up this position you develop and implement quality systems in compliance with the applicable legislation and standards to ensure continuous Quality Management System (QMS) certifications which is key for the sales of our in vitro diagnostics products.
Your key tasks will be to:
screen the regulatory environment to identify new QMS standards, regulations and guidelines;
perform and support different departments in the GAP analysis of QMS legislation;
translate QMS requirements into compliance and cost-efficient QMS documentation;
plan, prepare, coordinate and act as spokesperson during external audits;
prepare Management Review Meetings and propose improvements and solutions;
discuss and follow up actions plans regarding external audits and Management Review Meetings with involved stakeholders;
supervise the CAPA process within the organization;
establish the annual GxP training program;
develop, update and give GxP related trainings;
supervise the qualification process and ensure the compliant status of the training database;
stay up to date with the industry practice on QMS standards implementation by reading specialized literature, networking across the industry and interaction with regulatory authorities.
This position is offered as a full-time fixed-term contract of 2 years.
Your Profile
Master degree in bio-science (pharmacy, biology, biotechnology) or equivalent by experience
5 years experience in a high quality environment (ISO, FDA)
Very good knowledge of applicable GxP regulations
Excellent communication skills: power of persuasion / impact
Strong planning & organisation skills
Good problem solving / problem analysis skills
Project management
Customer-oriented
Creative and innovative
Open minded, cooperative & taking initiative
Languages: Dutch & English – good knowledge written & spoken
Why choose Fujirebio?
A challenging full-time position (fixed-term contract of 2 years) with a competitive salary and attractive benefits package
A dynamic and stimulating work environment where you contribute daily to advancing healthcare
A role with rich content and the autonomy to shape and organise your responsibilities independently
An open and informal company culture that encourages collaboration between scientific, operational, commercial, and support teams
Plenty of opportunities to develop your knowledge, skills, and talents within a certified Great Place to Work