Senior Quality System Process Manager

Are you passionate about quality system compliance in highly regulated environments while working across multiple global departments?

We are seeking a skilled and experienced Senior Quality System Process Manager to join Global Quality where we are 25 dedicated employees. The position focuses on ensuring governance, maintenance and compliance of ALKs Quality System across a GxP-regulated environment with linked quality processes and providing support to Global Quality stakeholders in quality system related matters.

The position
As the Senior Quality System Process Manager, you will be working with:
1. Operational tasks:

• Drive governance, maintenance and compliance of ALKs Quality System and cultivate a culture of quality in alignment with e.g., ICH Q9/Q10, EU GMP and FDA 21 CFR Parts 210/211, MDR.
• Actively participate in designing, implementing, training and continuously improving ALKs quality processes and provide QA expertise and support related to quality processes within e.g., Quality Risk management, Deviation handling, CAPA, Change control, Quality Management Review and Product Quality Review.
• Drive and ensure implementation of new regulatory requirements in ALKs Quality System and throughout ALK.
• Provide training to stakeholders in ALKs Quality System and quality processes.
• Facilitate quality process network groups.
• Prepare and handle Change Controls, Deviations, CAPAs and SOP/WIN approvals within the Global Quality area.
• Prepare, review, and approve SOPs/WINs within the Global Quality area

2. Project Participation:

• Participate in Global Quality improvement initiatives to enhance efficient quality processes and linked IT systems

3. Lead Auditor:

• Plan, execute, report and follow up on internal corporate GMP audits (EU, FDA) of ALKs Product Supply Sites.
• Facilitate and provide support for external audits and inspections from authorities and partners (e.g., FDA, DKMA)

Your profile
We expect that:

• You hold an academic degree in life science, engineering, or related field.
• You have at least 7 years of experience from the pharmaceutical or medical device industry and have experience with EU GMP, ICH Q9/Q10, FDA 21 CFR 210/211 and/or other GxP regulated areas
• You have extensive experience with governance and improvement of quality systems and quality processes with linked IT systems. Experience with Quality Risk Management will be an advantage
• Proven ability to manage complex initiatives, prioritize, and deliver on-time in a regulated setting.
• Have experience with GMP audits as Lead Auditor or participation in audits and authority inspections as SME

Your personal characteristics:

• Possess high drive and you take initiative and proactive action.
• Ability to work independently but also being a team player.
• Relation builder working respectfully across different cultures with flexibility.
• You have solid cross-cultural communication skills who excel both verbally and written in English and Danish.

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 specializing in allergy immunotherapy. We are driven by a high level of professionalism, integrity, an open-minded approach and contributing to an inspiring and fun working environment together with our colleagues. You will report to Senior Director, Global Business Operations and be part of an engaged and informal team who values skill and knowledge creation. The result of your efforts will be significant throughout the organization, 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 27. Feb 2026.
We commit to an inclusive recruitment process and equal opportunity for all our job applicants. Hence, we prefer that you do not add images to 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.

We are looking forward to hearing from you!