Skip to main content

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 balance of hands-on involvement in quality processes as well as providing regulatory guidance to support Client / Medace 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 will have experience interacting with health authorities (such as IGJ and EMA) and be comfortable navigating GMP guidelines and regulatory requirements. You should be able to balance hands-on quality processes with providing regulatory support in a dynamic environment.

 

Responsibilities

  • Collaborate with the Quality Team to ensure the successful implementation of GMP practices across Client and Medace 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 Clients
  • Develop and review project-specific regulatory and quality documentation (templates/guidance)
  • Develop and deliver training on quality and regulatory topics tailored to Client and/or Medace needs
  • Monitor and ensure continuous compliance with applicable GMP guidelines and regulations

 

Qualifications

  • Bachelor’s degree in life sciences, quality management, regulatory affairs, or a related field
  • 3-5 years of experience in quality assurance or regulatory affairs within a GMP environment
  • Comprehensive understanding of CMC principles and their application in 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
  • Good command of English, spoken and written
  • Detail-oriented, organized, and capable of managing multiple priorities

 

What we offer

Medace offers a challenging job in an inspiring, fast growing and ambitious organization. Communication lines are short and personal initiative is highly stimulated and appreciated. We offer a market conform full-time position. We are a team of enthusiasts committed to support your professional and personal development and give you the opportunity to cooperate with talented people in an informal, transparent, and open culture.

 

Interested?

Submit your motivation and resume via info@medacespace.com before November 25th, to be included in the first round.

If you have any questions regarding this vacancy, please contact Jessica Gerards (Quality Manager GMP) via mail: jessica.gerards@medacespace.com or phone: +31(0)6-18426609.

Acquisition as a result of this vacancy is not appreciated!

Due to the characteristics of Medace, we cannot accommodate sponsorships for non-EU citizens.

 

About Medace

Medace is a unique ISO 13485 certified and GMP compliant full service work-learning environment for the medical industry. Clients are taught and supported in developing their medical product themselves towards clinical implementation and regulatory clearance for market introduction. They receive training and obtain advice from our experienced personnel, learning from and building on our QMS template. We offer these in configurable packages allowing our Clients to adapt the support they need pending on the product development stage they are in. From access to our state-of-the-art research and cleanroom facilities and equipment, consultation on the smart way to make a compliant development and regulatory roadmap for specific regulated markets, to full support in building the quality management system and technical dossier needed for a clinical grade product.

Our Clients range from academic groups in the development phase to start-ups and scale-ups going through the preparations for submissions, with the focus audience consisting of start-ups active in the field of Cell Therapy, Tissue Engineering, API’s, Biologics, Medical Devices and Combination products (Medical Device – Medicinal Product). This results in a vivid biomedical co-working space where entrepreneurship, science and professionals thrive.

Get in touch

Contact Us - Cleanroom rental
First
Last

Training interest

Training interest
Name
Name
First
Last

Training registration

Training registration
I agree with the terms and conditions *

Brochure - MD

Training registration

Training registration
I agree with the terms and conditions *

Training interest

Register interest for training course

Get in touch

Call me back