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Head of Quality

Are you a senior Quality manager who is 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.

The European Clinical Research Alliance for Infectious Diseases (Ecraid) is an operational clinical research organisation dedicated to performing high-quality clinical research on infectious diseases and antimicrobial resistance. Ecraid focusses on two main areas: firstly, setting up and performing clinical trials, and secondly, developing and maintaining a large international hospital and primary care network.

Ecraid is dedicated to conducting clinical research that is embedded in medical practice and that focuses on patient needs. We are looking for a Head of Quality to develop and implement Ecraid’s quality management vision and strategy, which is aligned with our business strategy.

As a fast-growing organisation, a strong Quality Management System 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 a clear vision on Quality Assurance and the ambition to implement and improve quality standards and compliance in our organisation.

Who you are

The Head of Quality is responsible for the setting up and maintenance of our quality system (QMS) through our Standard Operating Procedures (SOPs) manuals and work instructions. You will ensure our compliance with national and international rules, regulations and contracts with health authorities that are involved with our operational activities, as well as perform (internal) audits independently and propose appropriate actions or solutions for improvements.

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.

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

  • 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
  • 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
  • An affinity with clinical research in the area of infectious diseases is a plus

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

What we offer

We offer a challenging and meaningful career opportunity in an inspiring work environment. Based in Utrecht, the Netherlands, you will be surrounded by intelligent, cooperative and enthusiastic colleagues. Your initial employment contract will be for one year, with the possibility of an extension. We offer a gross salary of between €4,325 and €6,215 monthly. This is based on your experience and a full-time work week of 36 hours.

Ecraid is purpose-driven, people-centered

Established in January 2022, Ecraid is a not-for-profit clinical research foundation dedicated to reducing the impact of infectious diseases in Europe. It is the long-term successor of the EU-funded projects COMBACTE and PREPARE. We are a fast-growing and diverse organisation of about 60 employees, working in an informal environment. We believe that talented people combined with personal development is essential to achieve excellent results.

  
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