Head of the Certification of Substances Department

European Directorate for the Quality of Medicines and HealthCare (EDQM)

Description & Requirements

Your Team

The mission of the European Directorate for the Quality of Medicines & Healthcare (EDQM) is to contribute to public health protection by engaging with an international community of experts and stakeholders. We achieve this by promoting access to safe medicines and healthcare through the elaboration of quality standards, which are recognised as a scientific benchmark worldwide. The EDQM's standards for medicines and their ingredients, compiled in the European Pharmacopoeia, are legally binding in 39 member states of the Council of Europe and are also widely used across the globe in the human and animal health sectors. The EDQM also plays a crucial role in the areas of blood transfusion, organ, tissue and cell transplantation and in developing and setting consumer health standards, such as for cosmetics and food contact materials.

The Certification of Substances Department (DCEP) is a committed team of approximately 60 professionals encompassing scientists, quality assessors, GMP inspectors, project managers and support and administrative staff with a diversity of backgrounds and expertise. DCEP is at the heart of the EDQM’s mission to protect public health by delivering robust, high-quality scientific assessments and regulatory guidance, ensuring implementation of the procedure for Certification of Suitability to the Monographs of the European Pharmacopoeia (CEP). Working in close collaboration with other EDQM departments and an extended international network of stakeholders, DCEP promotes a culture of co-operation, high performance and continuous improvement in support of high-quality and safe medicines across Europe and beyond.

Your Role

As Head of the Certification of Substances Department, you will:

• provide leadership as part of the EDQM Management Team by:
  • contributing to the formulation and achievement of strategic objectives; ensuring that the Department’s goals and activities align with the EDQM’s overall direction;
  • leading and co-ordinating cross-functional projects and programmes; supporting the development of organisational policy; ensuring effective co-operation between different areas of responsibility;
  • advising senior management on matters related to the Department’s work; ensuring the effective implementation of good practices.
• manage the Department, which comprises two divisions – Evaluation and Scientific Support and Inspection – and the Planning and Process Management Section, by:
  • setting clear objectives, allocating responsibilities and monitoring performance against agreed targets and indicators;
  • promoting co-operation, professionalism and high standards of conduct; ensuring a framework is in place to support and encourage staff with their development and training;
  • overseeing change-management processes; promoting a culture that is open to organisational evolution and learning and that enables agility as well as adaptation to emerging regulatory and scientific developments.
• optimise departmental processes and performance by:
  • fostering teamwork and continuous improvement across all functions;
  • monitoring key performance indicators (KPIs) and implementing improvements;
  • ensuring processes remain robust, efficient and responsive to changing requirements.
• communicate effectively and represent the Department and EDQM externally by:
  • engaging with internal and external stakeholders at all levels, including national/international authorities, partners and committees, to support the accomplishment of the EDQM’s objectives;
  • promoting the global visibility and acceptance of the CEP procedure;
  • participating in, and contributing to relevant committees, working groups and professional events as required.
• have extensive professional experience in management functions, including leading large multidisciplinary teams, ideally, in an international context related to medicines licensing authorities, official medicines control laboratories or the pharmaceutical industry;
• have a strong background in pharmaceutical legislation in Europe, a deep understanding of the scientific areas covered by the EDQM and solid experience in European and international co-operation;
• possess significant expertise in the evaluation of pharmaceutical data and regulatory submissions for the quality of pharmaceutical substances and/or medicines (Chemistry, Manufacturing and Controls – CMC);
• have excellent communication skills in English, both written and verbal, together with the ability to collaborate and partner with multiple stakeholders, and basic knowledge of French or capacity to acquire the knowledge on the job.

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