Vacature Quality Manager GMP

Quality Manager GMP in Maastricht

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 www.medacespace.com.

Job Description

As Quality Manager GMP, you are a member of Medace's Quality team with direct report to the CEO (next to the Quality Manager MD). In this position you take a hands-on leadership role in maintaining and improving Medace’s GMP QMS, thereby advancing our business strategies to serve both our in-house CMO activities as well as clients with their product development projects.

What are we looking for?

We are looking for a proactive and experienced Quality Manager GMP with a strong background in quality assurance and regulatory compliance, ideally within a CMO or GMP environment. The ideal candidate will have hands-on experience managing GMP processes to control supportive processes and implement product-specific processes, as applicable. The ideal candidate will combine strong leadership and collaboration skills with a solution-oriented, proactive mindset, capable of driving continuous improvement and ensuring the effectiveness of the Medace GMP QMS across all GMP operations.

Responsibilities

• Lead and oversee GMP quality activities across Medace’s CMO operations and Client projects within the Medace facility.
• Managing and overseeing the effectiveness of the QMS (GMP and alignment with MD QMS were applicable) to maintain a desired level of compliance and excellence.
• Provide quality and regulatory advice and guidance to both the Medace team and Clients related to hands-on GMP aspects as well as preparations for health authorities’ interactions.
• Conduct and coordinate self-inspections, supplier audits and external inspections.
• Collaborate closely with cross-functional teams (e.g. Operations and Biosafety) to align quality and operational tasks.
• Develop, deliver, and maintain training programs on GMP, regulatory requirements and Medace QMS processes.
• Act as a mentor and guide for the Quality team, fostering a culture of compliance, continuous improvement and quality awareness.

Qualifications

• BSc / MSc / PhD degree in life sciences with in-depth knowledge and expertise in quality management, regulatory affairs.
• 5+ years of experience in quality assurance and regulatory affairs within a GMP environment.
• 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.
• 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 €5,500 to €7,100 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.

Interested?

Submit your motivation and resume via [email protected] before March 15th, 2026.

If you have any questions regarding this vacancy, please contact Yvo Graus via mail: [email protected] or phone: +31(0)6-15655911

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 longer than necessary for this purpose.

Acquisition because of this vacancy is not appreciated!