Are you proficient in setting up a quality management system for a fast-growing organisation? We are looking for an experienced Head of Quality to ensure that our international clinical research programs are conducted in accordance with the ICH-GCP quality guidelines and European Clinical Trial Regulation.
About Ecraid


At Ecraid, we are committed to advancing clinical research in the field of infectious diseases by establishing a long-term, financially self-sustainable, clinical research network in Europe. Our mission is to join forces and collaborate to efficiently deliver high impact studies. Headquartered in Utrecht, the Netherlands, Ecraid is the first network of its kind in Europe to offer a single point of access to a pan-European clinical research network for infectious diseases that spans over 1,250 clinical sites and 900 laboratories across 42 countries.


The role
We are looking for a Head of Quality to develop and implement Ecraid’s quality vision and strategy, which is aligned with our business strategy. As a fast-growing organisation, a strong Quality Management System (QMS) is crucial to support our processes and activities while ensuring our high-quality clinical studies. For this, we are looking for a Head of Quality with solid experience in Quality Assurance & Quality Control, Risk Management and who can help us to further develop our QMS the ambition to implement and improve quality standards and compliance in our organisation.
The Head of Quality is responsible for the setting up and maintenance of our quality system (QMS) through our Standard Operating Procedures (SOPs), Work Instructions, forms & templates. You will ensure compliance with national and international law & regulations as well as perform (internal) audits independently and propose appropriate actions or solutions for improvements. You are heading up the Quality Department and are the key point of contact for all quality related questions from the operational teams, including non-compliances & CAPA management, Data Privacy matters and protocol & ICH GCP deviations.
Reporting to the Chief Operations Officer, you will focus on establishing, optimising and standardising business processes for our employees and subcontractors to support internal and external audits.


Two distinct candidate profiles are encouraged to apply:


Profile A: experienced Head of Quality
If you have several years of relevant work experience as a Head of Quality and enjoy contributing to scientific research and thrive in the academic world, this role is an ideal fit for you.


Profile B: experienced quality manager or quality advisor
Alternatively, If you are working in (international) clinical research in the (pharmaceutical) industry or academic environments and aspire to become a head of Quality this position provides an excellent starting point. You will undergo training to become within 1-2 years.

Requirements
To succeed in this role, the following knowledge, skills and experience are required:

• A master degree working and thinking level, obtained through education and/or experience. A master’s degree in business management, healthcare management Business Development, Product Management, or any related field. An equivalent of the same in working experience is also acceptable for the position.
• At least 15 years work experience and a minimum of five years’ experience in a quality assurance position working in (international) clinical research in the (pharmaceutical) industry or academic environments.
• Affinity with clinical research in the area of infectious diseases is a plus

• Solid track record in implementation of quality control and assurance processes
• Strong knowledge of (inter)national laws and regulations, ICH GCP, the European Clinical Trial Regulation and SOPs and use of applications (such as EDC tools)
• Highly proficient in the setting up and conducting of internal and external audits of international clinical research within an academic setting and from the perspective of the sponsor role.
• Experience in setting up and leading a team is advantageous

To perform well in this position, you will maintain a good oversight at all times, and conduct your work in a well-structured manner. You possess excellent communication and stakeholder management skills and are result driven. Next to this, you are decisive, purposeful, and can indicate clear boundaries when needed.


Join the movement
We offer a challenging and meaningful job in a purpose-driven work environment. Based in Utrecht, you will be surrounded by intelligent, collaborative and enthusiastic colleagues. This position is offered on a temporary one-year employment contract with potential for extension. We offer a monthly gross salary of between € 4.677 and € 6.722 that commensurate with experience and based on a full-time 36-hour workweek.


Interested in joining our mission?


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