Scientific Programme Manager – SoHO assessment schemes

The European Directorate for the Quality of Medicines & Healthcare (EDQM) is a leading organisation whose mission is to contribute to public health protection by engaging with an international community of experts and stakeholders. We achieve this by promoting acces to safe medicines and healthcare through the elaboration of quality standards, which are recognised as a scientific bookmark worldwide. the EDQM's standards for medicines and their ingredients, compiled in the European Pharmacopeia, are legally binding in its 39 member states (and the European Union) 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. 

You will work in the Quality Section of the Substances of Human Origin (SoHO) Division which is part of the Intergovernmental Committees and Networks Department. The Quality Section team is in charge of quality management activities such as quality assessment schemes.

As a Scientific Programme Manager – SoHO assessment schemes, you will:

• co-ordinate activities related to developing and implementing quality assessment schemes for SoHO establishments, primarily in the area of tissues and cells:

- lead the on-site and virtual assessment schemes;

- draft assessment reports for review and validation before release to the establishment concerned;

- follow-up on the corresponding action plans.

• advise the assessed establishments on the development and implementation of their quality management systems, in compliance with the requirements and/or recommendations laid down in the relevant EDQM SoHO guides on quality and safety and the new EU SoHO Regulation;
• provide technical and scientific support to assigned expert groups working on the aforementioned tasks;
• report on activities and projects, monitor expenditure and propose adjustments to support the establishment, management and implementation of EU/EDQM co-operation agreements and monitoring of associated relevant budgets and activity plans;
• promote the activities of the team, represent the EDQM at various professional events (including those organised by regulatory organisations), respond to stakeholders’ questions and providing technical elements to promote SoHO assessment activities on the EDQM website, etc.

• Operational - Planning and work organisation
• Operational - Drafting skills
• Interpersonal - Teamwork and co-operation
• Interpersonal - Communication

• Professional and technical expertise:

• experience in audit co-ordination;
• knowledge of the SoHO field.

  
  

• Operational - Analysis and problem solving
• Operational - Concern for quality

This job vacancy is for an international external recruitment. You can consult the conditions of employment (salaries, allowances, pension scheme, social insurance, etc.) on the webpage What we offer. 

For more information on how we recruit, you can consult the page Our recruitment process. This recruitment is carried out in accordance with Article 490 of the Council of Europe Staff Rules. The deadline for applications is indicated in the General information section of this vacancy notice (see above) and is fixed at 23:59:59 (CET/CEST). When applying, make sure your motivation shows how your competencies make your profile the best for the role.

As an equal opportunity employer, the Council of Europe welcomes applications from all suitably qualified people, irrespective of sex, gender, sexual orientation, ethnic or social origin, disability, religion or belief. Under its equal opportunity policy, the Council of Europe is aiming to achieve gender parity in staff employed in each category and grade. At the time of appointment, preference between suitable people shall be given to the person of the gender which is under-represented in the relevant grades within the category to which the vacancy belongs.

Applicants with specific needs are encouraged to request reasonable accommodations at any stage during the recruitment process. Please contact us at talents@coe.int, we will ensure that your request is handled.

The information published on the CoE’s careers website regarding working conditions is correct at the time of publication of the vacancy notice. Any changes to these conditions during the recruitment process will be updated on our Portal and will apply at the time of the job offer. Our career's website is not intended to be exhaustive and may not address all questions you would have. Should you have remaining questions, please contact us at talents@coe.int.