Quality Manager, Belgium - Diegem, België - Biogen

Beschrijving

Job Description About This Role**As the Quality Manager, you will play a pivotal role in overseeing all Quality Assurance activities within our Belgium affiliate. This position comes with the responsibility of being the Appointed Responsible Person/Qualified Person for the Belgian affiliate, ensuring the additional batch release required for products distributed in Luxembourg and Belgium. You will also lead in the maintenance of quality systems and the MIA License. You will report to the managing director. 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 maintenance

• Oversee the GxP documentation managements system for local policies and procedures
• Management of local deviations, CAPAs and change controls.
• Manage contacts with the Belgian and Luxemburg health authorities for GDP and GMP activities
• Consult and advise local affiliate on Quality matter on a as needed basis
• Management of the local procedures and Quality training program for all affiliate staff and vendors that act on behalf of Biogen
• Prevention of counterfeit. Ensure that suspected falsified product is immediately notified for investigation and coordinate local management of the issue
• Measurement 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 Biogen Belgium

• Lead, coordinate and perform selfinspections within Biogen Belgium NV.
• Lead and coordinate all local GxP audits and inspections including subsequent CAPA plan
• Monitor 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 Luxembourg
• Approve any returns to the saleable stock

Handle product complaints, product returns and product recall

• Investigate and follow up technical product complaints when necessary
• Investigate and follow up distribution complaints when necessary
• Approve 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 problem

Ensure that the Wholesalers License of the Belux affiliate is updated when necessary.

• Organize the local import release process
• Ensure that the MIA license is kept up to date

Vendor Management

• Ensure that the local GxP service providers are qualified
• Overview of the GxP activities of GDP Vendors

Functional learning liaison

• Work together with the Central Learning Services to ensure that the correct training curricula are assigned / removed to affiliate staff

- members

• Maintain records of the affiliate training completion.

Perform local QP Batch Release

• Work together with the logistics Intl team to ensure that all (financial imported) products distributed by Biogen Belgium are local QP released
• Keep the release register and release documentation uptodate
• Ensure that a backup QP is appointed

Act as Back-up Responsible Person for Biogen Netherlands

• Ensure QMS is implemented and maintained
• Coordination and promptly performing any recall operations for medicinal products
• Ensure relevant customer complaints are dealt with effectively
• Decide on the final disposition of returned, rejected, recalled or falsified products
• Approve any returns to saleable stock
• Ensure that any additional requirements imposed on certain products by national law are adhered to.

Who You Are

You are an experienced Quality Manager, 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.

Qualifications Required Skills**- Scientific Master's degree.

• 35 years experience in a similar role.
• Qualified Person batch release for human products registered by the FAHMP.
• Strong knowledge of local legislation.
• Able