Lead Quality Assurance Professional – Combination Products

Do you have proficiency in quality assurance of Medical Device and Combination Products from a GMP and regulatory requirements perspective Are you an impactful communicator with developed stakeholder management skills

The position
You will as Lead QA Professional be part of Global Quality and join a team of skilled colleagues.

Your main task will be to provide support and be directly responsible for a range of quality assurance functions related to medical devices and you will contribute to ensure that development and maintenance of Medical Device and Combination Products conforms to established regulation and internal ALK requirements. You will also demonstrate a high level of involvement in continuous improvement of the quality assurance philosophy and practice to ensure the right standards are implemented.

Your primary tasks will be:

• Quality and compliance support to Medical Device and Combination Products.
• Review and approve of component related documentation: drawings and quality control specifications for medical device and combination products.
• Review and approve of measurement and validation reports for component tools used for medical device and combination products.
• Review and approve of documentation related to Design Control for Medical Device and Combination products.
• Monitor quality and compliance performance of Global Device Development department.
• Provides on-site guidance in the preparation of procedures and working instructions.
• Assists in providing resolution to quality issues through identification of problem areas refinement of systems training and coaching of relevant personnel.
• Helps support a permanent inspection readiness status.
• Provide QA support for regulatory filings and in relation to supplier management activities.
• Provide quality expertise advice and/or assistance across the organisation as required.
• Perform external quality and vendor qualification audits risk assessments and write audit reports and follow up on observation close-outs.
• Provide quality support to technology transfer projects associated with devices.

About you
We expect that you have knowledge skills and experience gained in the pharmaceutical industry. Therefore we expect that you bring:

• Minimum of 5 years experience in the pharmaceutical/biotech industry with a thorough knowledge of Medical Device and Combination Products GMP and regulatory requirements including FDA.
• Masters degree in natural sciences pharmacy or equivalent.
• Experience with ISO 13485 and ISO 19011.
• Expertise in interdisciplinary areas of pharmaceutical sciences analytical chemistry microbiology sterile operations cGMP regulatory issues and data integrity regulation.
• Strong interpersonal and leadership skills in dealing with a variety of cultures on non-routine matters and in stressful situations be able to handle organisational complexity and ambiguity.
• Developed communication skills in both written and spoken English.

Become a part of ALK
ALK is a global pharmaceutical company specialized in allergy immunotherapy. ALK as a whole organisation provides a dynamic and accommodating work environment complete with inspiring and challenging assignments. Our flat structures attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making process. We consider our pioneering spirit coupled with our trustworthiness our winning formula.

We operate in a dynamic environment where agility and adaptability are key to success. The culture is informal yet professional encouraging a strong work-life balance while driving performance excellence. Your contributions directly influence the companys strategic direction making this an exciting opportunity for growth and impact. Our headquarter is in beautiful green surroundings in DTU Science Park in Denmark Hørsholm.

Join us at ALK and be a part of an organization that values integrity innovation and making a difference in the lives of those we serve. Do you want to learn more we encourage you to visit us .

Apply
With our ambitious Allergy strategy ALK is embarking on an exciting growth journey aiming to double the number of patients we help by 2030. We are expanding our reach developing new solutions and optimizing our operations to address the increasing global need for allergy care. Joining ALK means contributing directly to this impactful mission and helping millions live healthier lives.

Apply by attaching your CV and a short letter of motivation no later than 30 November 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 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 Senior Director QA Spain Jose Luis Garcia on(Mobile). We kindly ask you not to contact us with commercial inquiries.

We look forward to hearing from you!