Senior Director, Qualified Person, Quality Assurance for Site and CMC Development

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, 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.

Key responsibilities in this role will be:

• Be the Qualified Person on the Manufacturing and Importation Authorization, Danish Medicines Agency with a number of Delegated Qualified Persons in the team
• Be an active player from a QA perspective in supporting Product Supply, CMC Development and Clinical Trial Supply in Hørsholm
• Facilitate cross functional collaboration and stakeholder communication with the SVP, Product Supply and VP and SVP, CMC Development
• Safeguard quality and compliance (e.g., FDA and EU)
• 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 cost
• and working capital
• Maintain an 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
We expect that you bring:

• Minimum 10 years' experience from a global pharmaceutical industry within quality, manufacturing, product development and/or regulatory affairs
• Proven Leadership experience
• Pharmaceutical business understanding including 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 the management cycle.

Needed competencies required:

• 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
• Experience 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 and planning skills, problem solving
• 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. Do you want to learn more about our company, we encourage you to visit us at [xxxxx]

Apply
Apply by attaching your CV and a short letter of motivation, no later than 11 March 2025.

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 don't wait to apply! We reserve the right to take down the advert when we have found the right candidate.

We look forward to hearing from you!