QA Compliance Manager, Global Quality

Are you interested in working with Marketing Authorisation responsibilities and be involved in both GMP and GDP related topics? Do you get energy from working globally in close collaboration with many different cultures? And would you like to be part of ALK and make a difference for people with Allergy?
We are looking for a full time QA Compliance Manager, with GMP and GDP experience, to support cross functional collaboration at ALK Headquarter as well as collaboration with both external partners (CMO’s, warehouses, distributors and transporters) and ALK Affiliates around the world to ensure oversight and maintenance of MAH responsibilities.

The position
As QA Compliance Manager, you will become part of the Global Quality function located at the ALK Headquarter in Hørsholm, Denmark and be member of a committed, enthusiastic, and experienced team working with many different QA tasks, processes, and systems within different GxP areas. The role consists of tasks related to proactively setting the quality standards for activities related to a new business set up, and daily operational tasks, oversight, support and sparring. It is a global position including collaboration with many different functions and cultures, and where travelling is expected.

Your primary responsibility areas and tasks will be:

• Support the tasks related to keeping the oversight as the MAH by proactively develop and improve business processes within ALK as well as between ALK and the external partners in current and a new business set-ups. This includes supporting the development of new distribution set-ups needed in new markets and update of the internal ALK Quality Management System accordingly.
• Operational tasks such as batch record review, complaint handling, deviation handling, change management, supplier management, audit management and documentation reviews.
• Daily operation support, sparring and collaboration with internal departments and ALK affiliates as well as external partners in the supply chain.
• Audit of external partners (CMO’s, warehouses, distributors and transporters).

Your profile
We expect that you have the following qualifications:

• Experience working with GMP and/or GDP in a Quality department, production site, supply chain department etc.
• Experience with internal audits and audits of external partners (CMO’s, warehouses, distributors, and transporters) is an advantage.
• B.Sc. / M.Sc. in Health Science with 5+ years of experience within GMP and/or GDP regulated areas including experience with quality management systems and tools.

Personal characteristics:

• Strong drive and takes own initiatives and proactive action.
• Ability to work independently, but also a strong team player.
• Relation builder working respectfully across different cultures with flexibility.
• Excellent in verbal and written communication in Danish & English.
• Strong cross-cultural communication skills verbally as well as written.

Become a part of ALK
We provide an attractive working environment for individuals looking for both personal and professional development. 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. You will be part of an engaged and informal team who values skill and knowledge creation. The result of your efforts will be significant throughout the organisation, and you will be able to actively influence and challenge the status quo.

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 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.

Do you want to learn more about our company, we encourage you to visit us at www.alk.net. For further information regarding the position please contact Senior QA Manager Global Quality, Ann Storm Mowinckel on +45 61 66 56 14.

We are looking forward to hearing from you!