Quality Assurance Officer

About us

As a leading contract research, development, and manufacturing organization (CRDMO), Ardena partners with pharmaceutical companies of all sizes—from emerging biotech to global industry leaders—united by the mission to help biopharma innovators navigate drug development with precision, quality, and speed, bringing their molecules from discovery to the clinic and market. Our fully integrated services span drug substance and drug product development, manufacturing, nanomedicine, bioanalytical services, clinical logistics, state research, fill & finish, and CMC regulatory support.

With a rapidly growing international footprint, Ardena is home to over 750 professionals across six strategic locations - Belgium (Ghent), the Netherlands (Oss and Assen), Sweden (Södertälje), Spain (Pamplona), and the US (Somerset, New Jersey). Our open and transparent culture is built on collaboration, ownership, and innovation, guided by our We CARE values. We foster a communicative environment where mutual respect, accountability, and excellence empower our team.

We are looking for skilled and motivated professionals eager to grow their careers in an exciting and fast-paced environment. Whether you’re an experienced expert or just starting out, Ardena provides a dynamic workplace where you can contribute to meaningful drug development projects, expand your knowledge, and be part of a global team committed to making a difference. As an international organization, we help you navigate a career path that expands your possibilities beyond borders, opening doors to personal and professional growth without limits. Your potential to grow is limitless with us.

For the Ardena Bioanalysis Division based in Assen and Oss, The Netherlands, we are looking for a:

Quality Assurance Officer

Our bioanalytical laboratory is a highly specialized, GLP-compliant facility offering a wide range of bioanalytical services to global pharmaceutical partners, from early drug discovery to Phase IV clinical studies. Our mission is to provide precise quantitative and qualitative analyses of drugs and biomarkers in biological matrices using cutting-edge techniques, including LC-MS/MS, ligand-binding assays (ELISA), qPCR, and flow cytometry.

Our growing team of bioanalytical scientists brings expertise across diverse fields, covering small molecules, peptides, cells, and proteins—such as antibodies, antibody-drug conjugates, oligonucleotides, and nanoparticles.

Your Role

As a Quality Assurance Officer, you will be responsible for planning, conducting, and reporting on various audits within the bioanalytical division. You will actively monitor and follow up on audit findings, ensuring compliance with GLP requirements and industry regulations. You will collaborate closely with internal teams and external stakeholders, ensuring that quality standards are met and continuously improved.

Your Responsibilities

• Planning, conducting and reporting of study-, process-, facility- and supplier qualification audits.
• Monitoring and follow-up on audit finding responses.
• Facilitating regulatory inspections and sponsor audits.
• Involvement in quality improvement projects and activities.
• Maintenance of the quality management system.
• Training and guidance on GLP requirements and best practices.

Your Profile

• Eligibility to work in the Netherlands (valid work permit or EU citizenship required).
• Strong knowledge and practical experience with GLP quality management principles, 21 CFR Part 11 regulations, and GAMP guidelines.
• Proactive Mindset: You take initiative, demonstrate persistence, and maintain a solutions-driven, can-do attitude in your work.
• Strong Interpersonal Skills: A skilled networker with excellent negotiation, problem-solving, and analytical abilities.
• Attention to Detail: You are accurate, proactive, critical, decisive, and adaptable, ensuring compliance and continuous quality improvement.
• Collaborative Approach: A team player who thrives in a dynamic environment, working effectively with both internal teams and external stakeholders.
• Educational Background: A bachelor’s degree or equivalent relevant experience in a related field.

What We Offer

• Salary range: € 3000,- to € 4500,- gross per month (based on a 40-hour workweek).
• A true learning environment where you will have the ability to grow your skills.
• A dynamic working environment with friendly and enthusiastic colleagues.
• A company culture with open communication, where employee well-being is highly valued.
• An attractive remuneration package
• Flexible working hours to support work-life balance.

Work Location: This is an on-site role, based in Assen, the Netherlands.

Ready to apply? Please click on the application button.

Only candidates eligible to work in the EU will be considered for the position. Unfortunately, given the high volume of applications we receive for our vacancies, these professionals (not entitled to work in the European Union) will not be given a status update. Agency calls will not be appreciated.