Senior Director, Qualified Person, Quality Assurance (QA) for Site and CMC Development Hørsholm

Do you bring proven leadership skills from working in a global pharmaceutical company and do you get energy from working in close collaboration with colleagues across different functions and from different cultures Join us on our exciting journey to drive our Allergy strategy and become our new colleague in Global Quality.

We are looking for a Senior Director Qualified Person QA for Site and CMC Development Hørsholm to support cross functional collaboration at ALK Site Hørsholm as well as collaboration with both external partners (Danish Medicines Agency) and ALK globally.

The position
In the role as Senior Director Qualified Person QA for Site and CMC Development Hørsholm you will be responsible for a team of approx. 40 employees located in Denmark and you will be part of a global leadership team reporting to the SVP Global Quality.

You will be the Qualified Person on the Manufacturing and Importation Authorization Danish Medicines Agency with several Delegated Qualified Persons in the team and be an active player from a QA perspective in supporting Product Supply CMC Development and Clinical Trial Supply in Hørsholm.

You will facilitate cross functional collaboration and stakeholder communication with the SVP Product Supply and VP and SVP CMC Development to safeguard quality and compliance (e.g. FDA and EU).

Key responsibilities in this role will be:

• Maintain QA oversight at Site Hørsholm.
• Ensure general efficiency improvements quality development and cost-consciousness.
• Reinforce Quality Standards and Performance.
• Ensure license to operate by being overall responsible for regulatory and GMP compliance of ALK services and products released within area of responsibility.
• Contribute to implementing business strategies related to ALK A/S quality system and compliance.
• Develop and optimise existing quality and business processes.
• Ensure processes and systems are aligned to be able to scale and ensure effective development execution from a quality perspective.
• Bring the Hørsholm site together with the rest of the management into quality compliance incl. the addition of the quality aspects of the development activities.
• Maintain the Quality mindset and culture of excellence and sustainable improvement in key dimensions such as responsiveness reliability and flexibility.
• Drive operational excellence by delivering process improvements that improve service reduce costand working capital.
• Maintain efficient and effective quality organisation and quality processes whilst implementing best practices.
• Cultivate a dynamic team environment with a high standard passion for learning and having fun while delivering results.

Your profile
You have minimum 10 years experience from a global pharmaceutical industry within quality manufacturing product development and/or regulatory affairs combined with proven leadership experience.

You possess a diploma certificate or other evidence of qualifications awarded on completion of a university course extending over a period of at least four years. And the course must include one of the following basic subjects: pharmacy medicine veterinary science pharmaceutical chemistry and technology chemistry or biology.

You are expected to have:

• Pharmaceutical business understanding with in-depth knowledge about regulatory and GMP requirements.
• Experience from working with improving business practices/working procedures.
• Experienced in working with high impact stakeholders e.g. authorities strategic business partners.
• Experience from setting up and working with performance management KPIs including themanagement cycle.

Leadership and personal traits needed:

• Solid ability in building relationships with internal and external stakeholders.
• Able to handle conflicts and create win-win situations.
• Developed leadership capabilities.
• Solid collaboration skills internally and externally securing influence and handling diverse and complex situations.
• Excellent organization planning and problem-solving skills.
• Strategic thinking and proactivity.
• English proficiency at business level both verbal and written.

Become a part of ALK
ALK is a global pharmaceutical company specialised in allergy immunotherapy. We are driven by a high level of professionalism integrity an openminded approach and contributing to an inspiring and fun working environment together with our colleagues. We provide an attractive working environment for individuals looking for both personal and professional development. You will be part of an engaged and informal team who values skill and knowledge creation.

Our offices in Denmark offer a green view of the DTU Science Park in Hørsholm. We believe that physical presence enforces strong teamwork and collaboration and creates success so it is important that you enjoy coming to work at our site with a degree of flexibility to also work from home.

Apply
Apply by attaching your CV and a short letter of motivation no later than 31 January 2026.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. Hence we prefer that you do not add images in your application documents. We evaluate applications and call for interviews on an ongoing basis so dont wait to apply! We reserve the right to take down the advert when we have found the right candidate.

For further information regarding the position please contact Jan Engel Jensen SVP Global Quality by email to We kindly ask you not to contact us with commercial inquiries.

We look forward to hearing from you!