Main purpose

The QA Coordinator manages the  setup, implementation, maintenance and the improvement of the Quality Management System. An important aspect of the role is to continuously promote quality awareness within the company and to participate in business and operational improvement and re-engineering  processes and initiatives in order to improve quality and to enhance efficiency. Finally, the QA Coordinator informs and advices the Management Team on quality related matters.


  • To set up, implement and maintain the Quality Management System
  • To manage the execution of the Quality Policy
  • To provide leadership, advice and support on quality topics and ensure adequate implementation of company procedures by actively engaging with department heads and their staff
  • To stimulate continuous improvement of the quality of the delivered services
  • To promote quality awareness and adherence by advising colleagues throughout the entire organization on the applicable guidelines and procedures


  • To define and to contribute to the achievement of the (annual) quality goals
  • To identify, report and take appropriate action for detected quality needs and quality opportunities
  • To coordinate the development, implementation, maintenance and adaptation of the Quality Documents
  • To contribute to the identification, assessment and follow-up on incidents, as well as to the definition and implementation of CAPAs and effectiveness check
  • To keep track of all incidents and related CAPAs
  • To assist the Data Protection Officer (DPO) in tracking and follow-up of DSAR & Data Breaches
  • To keep overview of critical vendors, to assist in the selection and regular evaluation
  • To organize internal audits, to host audits from clients and to follow-up on audit results and agreed CAPA plan
  • To follow-up on results of audits of vendors and implementation of agreed CAPAs
  • To file and track internal staff’s CV and training documentation (non-trial related training)
  • To stay abreast of (changes in) legislation and legal practices, and to take adequate action (e.g. adaptation of procedures)
  • To respond to comments, questions and requests related to quality and efficiency issues, both from internal and external parties
  • To provide quality training to newcomers and to contribute to ClinOps meetings for quality related items
  • To contribute to TMF reviews
  • To ensure proper filing and archiving of all quality related records

Job criteria

Degree in life science, preferably higher vocational education or academic degree

At least 3 years experience in any aspect of clinical development. Experience in a quality related function is required.

Dutch and English

Microsoft Office 365 applications

Excellent knowledge of ICH-GCP and all applicable regulatory requirements. Excellent knowledge about quality management systems. Experience with ISO9001:2015 is a plus.

  • Diplomatic
  • Excellent communication skills (spoken – writing – one-on-one –  in group)
  • Team player
  • Eager to learn
  • Problem solver and analytical capabilities
  • Working independently

Application QA Coordinator

Reference number : HAR23009-ST

Location : Melle/Home office

Application form

"*" indicates required fields

Accepted file types: pdf, doc, docx, Max. file size: 256 MB.
Accepted file types: pdf, doc, docx, Max. file size: 256 MB.

By submitting your CV to HarmonyCR, you agree that we will handle your personal data in compliance with our privacy statement as published on this website.

This field is for validation purposes and should be left unchanged.

Contact Harmony Clinical Research

Please feel free to contact us in case you have questions about HarmonyCR, or the services we offer. We thank you for your interest.