Company : Biogen Location : Machelen Flanders From : Talent BE
You will mainly work together with Logistics Intl, ComQ, the Belgian Biogen team and Quality managers of other countries.What You’ll Do Local Quality Management System Development and maintenanceOversee the GxP documentation managements system for local policies and proceduresManagement of local deviations, CAPAs and change controls.Manage contacts with the Belgian and Luxemburg health authorities for GDP and GMP activitiesConsult and advise local affiliate on Quality matter on a as needed basisManagement of the local procedures and Quality training program for all affiliate staff and vendors that act on behalf of BiogenPrevention of counterfeit.
Ensure that suspected falsified product is immediately notified for investigation and coordinate local management of the issueMeasurement of the achievement of Quality Management System objectives.Lead local implementation and alignment of Global Quality Management Systems.Act as the local coordinator of Product Recall, participate in Recall Committee when impacted product is distributed in the country.Management of local training program (GxP)Act as Responsible Person for BiogenBelgiumLead, coordinate and perform self-inspections within BiogenBelgium NV. Lead and coordinate all local GxP audits and inspections including subsequent CAPA planMonitor the affiliate Quality Standards in collaboration with all relevant internal stakeholders in order to ensure the affiliate complies with the highest quality standards.Ensure that the local MIA license is updated when needed.Develop and maintain local quality agreements.Ensure that suppliers and customers are approved in coordination with responsible departments.Decide on the final disposition of returned, rejected, recalled or falsified products in Belgium and LuxembourgApprove any returns to the saleable stockHandle product complaints, product returns and product recallInvestigate and follow up technical product complaints when necessaryInvestigate and follow up distribution complaints when necessaryApprove from a quality perspective all returns that have left supply chain.Act as the local coordinator of Product Recalls, participate in Recall Committee when impacted product is distributed in the country.Ensure product replacement in case of a quality problemEnsure that the Wholesalers License of the Belux affiliate is updated when necessary.
Organize the local import release processEnsure that the MIA license is kept up to dateVendor ManagementEnsure that the local GxP service providers are qualifiedOverview of the GxP activities of GDP VendorsFunctional learning liaisonWork together with the Central Learning Services to ensure that the correct training curricula are assigned / removed to affiliate staffmembers Maintain records of the affiliate training completion.Perform local QP Batch ReleaseWork together with the logistics Intl team to ensure that all (financial imported) products distributed by BiogenBelgium are local QP releasedKeep the release register and release documentation up-to-dateEnsure that a backup QP is appointedAct as Back-up Responsible Person for Biogen NetherlandsEnsure QMS is implemented and maintainedCoordination and promptly performing any recall operations for medicinal productsEnsure relevant customer complaints are dealt with effectivelyDecide on the final disposition of returned, rejected, recalled or falsified productsApprove any returns to saleable stockEnsure that any additional requirements imposed on certain products by national law are adhered to.Who You Are You are an experienced QualityManager, responsible for overseeing all Quality Assurance activities, including batch release, GxP documentation, and local deviations.
As the Appointed Responsible Person/Qualified Person, you have managed quality systems, the MIA License, and liaise with health authorities.
Proven expertise in product recalls, vendor management, and handling product complaints is essential.
You have a strong background in GxP-regulated environments, attention to detail, and effective leadership skills.QualificationsRequired Skills Scientific Master’s degree.3-5 years experience in a similar role.Qualified Person batch release for human products registered by the FAHMP.Strong knowledge of local legislation.Able to understand and optimize internal processes.Technical competences on quality link to Biogen market organization.Language:
Dutch, English, French.Additional InformationWhy Biogen?Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team.
We work together to overcome obstacles and to follow the science.
We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine.
Together, we pioneer.
Together, we thrive.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve.
We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.
to learn more about our DE&I efforts Biogen MachelenFlanders
