Vacancy List Details

Vacancy List Details

Sr. Quality Management Associate

Utrecht, The Netherlands

The team
Our Quality Management (QM) department with the research and pre-clinical area assures that our employees work conform the high quality standards of Genmab. The QM team is responsible for several quality processes related to research and pre-clinical activities, such as archiving, document control, process audits, and support of quality related activities performed within our line expertise. Although we do not operate under pharmaceutical GLP, GMP or GCP, we support research activities that feed into these regulated environments. 

The position
Together with two QM colleques you will be responsible for various quality related processes.

Your operational focus will be:

  • Review and approval of quality related documents, such as research study protocols, research study reports and certificates of analysis
  • Performing internal process related audits and external vendor audits, and monitoring the follow up of suggested actions
  • Functional administrator of quality related applications and databases
  • Giving quality related advice on an ad hoc basis to employees, e.g. related to qualification of equipment and computer systems
  • Training of personnel in quality specific activities
  • You will work in close collaboration with various employees and external partners (i.e. experts, operations and resource managers, research associates)

Furthermore you will oversee activities of your two QM colleagues with focus on:​

  • Life cycle management our quality related documents
  • Document control, supporting correct use of templates and issuance document codes
  • Archiving of documents, including documents for regulatory filing

In addition, you will give direction to QM process improvement and definition of QM goals:​

  • Translating strategic QM development to specific QM goals
  • Signaling strategic QM developments based on the long term company goals and external developments in the quality field
  • Optimizing the QM processes: maintaining a flexible, high quality and fit for purpose QM processes to accommodate the chancing Genmab environment
  • Being a business partner where there are possibilities to align with core processes 

Your professional profile

  • You have a higher education, with several years of experience in the field of life science and quality management
  • You have worked in the field of drug development, with experience in GLP, GCP and/or GMP environment
  • You have hands-on experience with equipment and computer qualification and validation
  • You have a ‘getting things done’ mentality and are well-organized, pro-active, enthusiastic and good at planning and organizing
  • You are driven to perform administrative processes
  • You have an eye for detail and you work in a structured manner
  • You are well able to collaborate with a diverse group of people and are able to support them to establish optimized processes
  • You have excellent communicative and relational skills
  • You are fluent in English, both verbally and in writing

Dynamic and innovative environment
Genmab employees have a passion for scientific innovation that leads to the development of break-through medicines which benefit patients. We collaborate in multifunctional and international teams in which individuals strive for excellence in order to reach common goals.  Our employees work with determination and respect for each other. Genmab stimulates continuous growth in employees’ knowledge and competences.

How to apply
Yacht recruitment agency has been appointed by Genmab to perform the full search and selection for this position. If you're interested in this role, please send your application letter, including resume, mentioning the position concerned to, before November 28th, 2017.

For detailed information on this vacancy you can contact Edith Gardenier via

Acquisition in connection with this advertisement is not appreciated.