If you are interested in quality and regulatory requirements within the Medical Device industry and want to take part in assuring quality and patient safety through robust Quality System processes, you might be our new QA Manager.
Immudex is an innovative biotech company, providing solutions for T-cell immune monitoring within immunotherapy, transplantation, infectious disease, and autoimmunity. Based on our proprietary Dextramer® technology, we market research reagents, enabling researchers, developers, and clinicians to measure disease-specific T-cell responses.
About the job
As the only QA responsible you will be hands-on with a variety of daily tasks having the main purpose of ensuring compliance with Immudex’ Quality Management System (QMS) and applicable international standards and regulations. As well as maintaining and improving the QMS.
However, even though a high degree of independence in your work is required, you will have a close collaboration with the entire Immudex’ Operation.
This position does not have personnel responsibility.
In more detail, this will include:
- Updating, maintaining and release of standard Operating Procedure (SOP)
- Handling non-conformance issues and corrective and preventive actions (CAPA)
- Ensuring and verifying compliance through internal audits
- Hosting during regulatory inspections from notified body
- Participating in design control projects of new developed products and design changes
- Supporting and approving validation and equipment qualification protocols and reports
- Review of batch record in relation to product releases
- Facilitating Management Review and collecting and analyzing data
- Train personnel in quality related processes as well as GMP
Qualifications
You have minimum 4 years in QA, preferably from IVD medical device industry.
Ideally, you have the following qualifications:
- Bachelor’s/Master’s degree in engineering, life science, pharmacy, or equivalent.
- Structured and have a strong attention to detail
- Able to work in cross-functional collaboration
- Responsible, helpful, and a skilled coordinator
- Proficient in oral and written English and fluent in Danish.
About you
We are looking for a person with an interest in quality assurance who can work independently and at the same time is a great team player. A person that is eager to develop within the field of QA. We are seeking a new colleague who works professionally and is cooperative as well as proactive. You have a high attention to detail and also keep a sense of perspective.
This position and your responsibilities can grow and evolve over time.
What do we offer
Immudex offers a dynamic workplace in an innovating, international, and diverse company where everybody is highly valued. We have an informal work environment characterized by dedicated employees with a desire to make a difference.
We offer a pension plan and healthcare insurance.
Besides that, you have the possibility to join the canteen scheme for a diverse lunch.
Colleagues will encourage you to participate in the crazy cake club or office exercises.
The position is full-time and based in our cozy headquarters, Bredevej 2A, 2830 Virum.
We aim for the start of the position on October 1st 2026, and we plan to conduct interviews in August 2026. However, we encourage you to send your application and CV as soon as possible.
If you have any questions about the position, please contact Patrik O. Dahlén, CEO by mail pd@immudex.com
About Immudex
Immudex ApS is a pioneering life science company and the trusted partner of scientists worldwide spearheading the global adoption of precision cellular immune monitoring. Immudex’s mission is to help researchers and clinicians unravel the complexity of the immune system, enabling the development of more effective immune-based therapeutics and diagnostics.
Immudex operates globally, with headquarters in Copenhagen area, Denmark, and North American operations based in Fairfax, Virginia. Immudex’s Dextramer® technology is superior for the detection of antigen-specific immune cells, including rare and low-affinity cells. Immudex offers a broad product portfolio that allows scientists to investigate diverse types of immune cells, including T cells, non-conventional T cells and B cells, with reagents tailored to specific applications. Immudex’s products are compatible with multiple platforms from flow cytometry to next generation sequencing and single-cell multi-omics.
In addition to Dextramer® reagents for basic research, Immudex also provides Clinical-Grade Dextramer® (GMP) products and Dextramer® CMV Kits (IVD) manufactured in ISO 13485:2106-certified facilities, according to the requirements of FDA QSR 21 CFR 820. Immudex’s products enable scientists to get the full picture of the immune response, supporting ground-breaking advances within immuno-oncology, transplantation, autoimmune and infectious diseases.
Find out more at www.immudex.com.
