Quality Associate GMP - Maastricht, Limburg

About Medace · Medace is a unique ISO 13485 certified and GMP compliant clean room facility to support development and production of biomedical innovations. We support clients in the development of their medical device or ATMP/medicinal product from initial concept until final pr ...

Functieomschrijving

About Medace

Medace is a unique ISO 13485 certified and GMP compliant clean room facility to support development and production of biomedical innovations. We support clients in the development of their medical device or ATMP/medicinal product from initial concept until final product produced according to the applicable regulations. The experienced Medace team provides the know-how and advice to clients to advance their product towards clinical validation and regulatory clearance for market introduction. In addition, Medace can produce client products as a Contract Manufacturing Organization.

A flexible model allows customized support in line with the product development stage of the client product. Medace offers state-of-the-art research and cleanroom facilities, a extensive equipment base for a broad range of products. Based on expert knowledge, the team supports the design of regulatory roadmaps for specific regulated markets and supports building and maintaining a quality management system and technical dossier needed for a clinical grade / MDR compliant product.

Our clients range from academic innovators, start-ups to scale-ups going through the various product development steps and preparations for submissions. Currently Medace aids companies in the field of Cell Therapy, Tissue Engineering, API's, Biologics, Medical Devices and Combination products (Medical Device – Medicinal Product). This results in a diverse biomedical co-working space where entrepreneurship, science and professionals synergize.

For more information about Medace visit 

Job Description

As Quality Associate GMP, you are a member of Medace's Quality team reporting to the Quality Manager GMP. This role involves a combination of hands-on involvement in quality processes as well as providing regulatory advice to support clients / CMO projects. You will play a key role in implementing GMP practices, ensuring adherence to regulatory requirements, and developing training materials as well as quality and regulatory documentation that meet project-specific needs.

What are we looking for?

We are seeking a proactive and knowledgeable Quality Associate GMP with a strong foundation in quality assurance and regulatory support. The ideal candidate has experience interacting with health authorities (such as IGJ and EMA) and is comfortable navigating GMP guidelines and regulatory requirements. You should be able to balance hands-on quality processes with providing regulatory support in a dynamic multi-client environment.

Responsibilities

·       Collaborate with the Quality Team to ensure the successful implementation of GMP practices across various projects, maintaining compliance with regulatory requirements.

·       Provide regulatory advice and guidance concerning permits, approvals, and registrations for medicinal products, including interactions with health authorities (e.g. IGJ and EMA) related to these aspects, as well as consultation services regarding the EMA (e.g. ATMP classification and Scientific Advice).

·       Review CMC sections of the IMPD /ASMF filling of client projects.

·       Develop and review project-specific regulatory and quality documentation (templates/guidance).

·       Develop and deliver training on quality and regulatory topics tailored to client needs.

·       Monitor and ensure continuous compliance with applicable GMP guidelines and regulations.

Qualifications

·       BSc / MSc degree in life sciences with in-depth knowledge of quality assurance, regulatory affairs.

·
+
 years of experience in quality assurance or regulatory affairs within a GMP environment.

·       Comprehensive understanding of CMC principles and their application in ATMP/pharmaceutical development.

·       Knowledge of regulatory interactions, with experience engaging with health authorities (e.g. IGJ and EMA).

·       Extensive experience in developing and reviewing quality and regulatory documentation.

·       Ability to train people on the contents and use of GMP guidelines and related regulations.

·       Experience with active pharmaceutical ingredient (API) quality and regulatory aspects is a plus.

·       Strong problem-solving skills and a team player.

·       Fluent in English, spoken and written.

·       Detail-oriented, organized, and capable of managing multiple priorities.

What we offer

Medace offers an inspiring job in a fast growing and ambitious organization. Communication lines are short and a proactive attitude is highly stimulated and appreciated. We are a team of dedicated enthusiasts committed to supporting your professional and personal development and give you the opportunity to work with talented team members in an informal, transparent, and open culture. We offer a full-time position (40 hours per week) with attractive remuneration. Salary is based on education and experience and ranges from €4,500 to €6,300 plus holiday allowance of 8%. The secondary benefits are excellent, including a generous leave policy, a pension plan and additional insurance. The initial appointment is for one year, with the possibility of permanent employment. Candidates must have the possibility to work in the Netherlands / have permanent authorization to work in the Netherlands.

Interested?

Submit your motivation and resume via before March 15th, 2026.

If you have any questions regarding this vacancy, please contact Yvo Graus via mail: or phone:

The personal data you provide in the context of this application will be used exclusively for the selection and application process and will be treated confidentially and not kept for longer than necessary for this purpose.

Acquisition because of this vacancy is not appreciated