Head of Section for the Medicines Agency's Inspection

Do you want to lead an area of great importance for the safety of medicines and medical devices? Are you motivated by leading a team of team leaders and skilled specialists who each day monitor companies and products in areas with high professionalism and great societal significance?

Can you set direction in a complex and regulated professional field and at the same time create well-being, development and engagement among the employees? Do you have an eye for both daily operations and the continued development of our tasks?

Then you may be our new Section Head for Inspections at the Danish Medicines Agency (Lægemiddelstyrelsen).

Your primary tasks

As Section Head you will lead through your three team leaders and yourself perform personnel management of a team of inspectors. In addition, you will have the professional responsibility for the Inspection. You must ensure stable and efficient operations with high professional quality and at the same time contribute to the ongoing development of our inspection and control tasks.

You must create good frameworks for the individual areas of expertise and strengthen coherence, prioritization and collaboration across the section.

Your key tasks are to

• Lead the section professionally and in terms of personnel management with a focus on well-being, engagement, quality and results.
• Motivate and develop employees through dialogue, trust and ongoing feedback, and ensure a strong collaboration culture in close coordination with unit management.
• Set a clear direction and create forward momentum through sharp prioritization across the section’s four teams.
• Ensure stable and efficient operations of the inspection and control tasks and continuously follow up on quality, resources and deliveries.
• Ensure compliance with the requirements in our DANAK accreditation
• support a strong quality culture and systematic follow-up in collaboration with the employees.
• Support the professional development and knowledge sharing across the section.
• Contribute to further development and efficiency of workflows and processes.
• Represent the area and contribute to good collaboration with companies, other authorities and relevant partners.
• Actively participate in unit management and contribute to collaboration, development and prioritization of tasks in Corporate & Control (Virksomheder og Kontrol).
• Handle orders from the ministry and contribute input to political processes and legislation.
• Provide professional input to responses to press inquiries.

Your everyday life with us

You will play a central role at the intersection of professionalism, operations, development and leadership. The everyday life is characterized by both ongoing inspection and control tasks and development activities, where you together with the employees must ensure prioritization, progress and high quality.

Quality and systematic thinking are important parts of our work, and as Section Head you will play a central role in ensuring that we maintain and develop our work within the framework of the DANAK accreditation (ISO 17020).

You will become the leader of employees with strong specialist competencies. An important part of your task will therefore be to create frames where employees’ expertise can be used in the best possible way, while ensuring a clear common direction. You must be able to give space to the professional area and at the same time be clear when decisions must be made.

You will have an important role in the collaboration across the Medicines Agency and with our external partners. The inspection area is characterized by extensive regulation and cross-disciplinary cooperation across both professional areas and borders, and you must therefore be able to navigate a daily life with many stakeholders and different considerations.

You will become part of the Medicines Agency’s extended leadership team and a leadership network where strong cross-functional collaboration and good leadership are important agendas. In addition, you will be part of the management for Enterprises & Control (VIK), where you report to the unit head.

About the section

The Inspection consists of four teams: GDP & Pharmacy, GMP, GCVP and Medical Devices, in total about 40 employees. The employees work with inspection and control of areas that affect the quality and safety of medicines and medical devices.

We are a cross-disciplinary section with employees who have different professional backgrounds and strong specialist competencies. We place emphasis on high professionalism, quality and accountability, but also on collaboration and helping each other to succeed.

Your education, experience and personal qualifications

You have a relevant advanced natural science education. You master leading strong professional groups and creating direction, results and well-being in a complex organization.

We expect you to bring several of the following experiences

• Leadership experience, preferably as a people manager for employees with strong professional or specialist-oriented competencies.
• Solid experience from the pharmaceutical or medical device industry and a good understanding of the regulatory requirements and terms in the industry.
• Familiarity with inspection work in the pharmaceutical area and the area of medical devices.
• Experience in leading an operational organization with a focus on quality and deliveries.
• Experience from a politically governed organization, an authority or another complex and regulated organization.
• Experience with development and improvement of workflows and processes.
• Experience with quality management, DANAK accreditation and ISO 17020.
• Experience with collaborating with the ministry and across professional disciplines and organizational boundaries.

We especially emphasize that you

• Are a clear and trust-based leader who can set direction and create followers.
• Can lead employees with great professional expertise without feeling the need to present yourself as the biggest specialist.
• Have a view for both operations, development, results and the people who create them.
• Are systematic and have a sense of quality and prioritization.
• Communicate clearly and respectfully both internally and externally.
• Are curious about different professional areas and can bring them together.
• Make decisions and follow them through.
• Actively and constructively contribute to the joint collaboration and leadership responsibility in the unit and across the Medicines Agency.

We offer

• A leadership job with great societal impact and the opportunity to make a concrete difference.
• An exciting and varied daily life, where you work at the intersection of leadership, professionalism and development.
• A strong leadership community with a focus on collaboration, sparring and development.
• Skilled and committed employees with high professionalism and a high level of responsibility for their areas.
• Good and flexible working conditions, including the possibility of remote work.
• Good facilities at Islands Brygge, close to the metro and S-train, as well as parking for cars and bicycles.
• Access to good coffee, an active staff association, an arts association and a morning song.

About Enterprise & Control

Enterprise & Control is a unit with three sections, each with several teams and about 92 employees, including pharmacists, chemists, laboratory technicians and clerical staff.

The unit is responsible for approval, registration and monitoring of companies that perform tasks with medicines, as well as control of companies that perform tasks with medical devices. The unit is also responsible for control of medicines and clinical trials. The unit handles applications for business licenses. The unit also participates in the development and implementation of the European Pharmacopoeia, which sets requirements for the technical quality of medicines in Europe.

The unit is also responsible for monitoring illegal trade of medicines, administration of narcotics regulations and fulfilling the role of the national cannabis agency. Finally, the unit handles reports of product defects in medicines and assessment of the need for any recalls from the market.

Read more about us and our work at Lægemiddelstyrelsen.dk .

About the employment

You will be employed under the applicable collective agreement between the Ministry of Finance and the Danish Confederation of Professional Associations .

At the Danish Medicines Agency we make decisions in official matters, and it is important to us that no one can question our impartiality. Therefore, it is a condition that you do not own shares, portion certificates, equity or similar in a pharmaceutical and/or medical device company. However, you have some time to sell them if you currently own so-called employee shares in a pharmaceutical and/or medical device company.

Feel free to contact us

If you would like to hear more about the position, you can contact the unit head Nina Elisabeth Bøggild at tel. 29 21 86 41.

You can read more about us and our tasks at Lægemiddelstyrelsen.dk .

Are you interested?

Click on "apply for the position" and send us your application with CV and diploma.

We expect to hold interviews in weeks 45 and 46.