Introduction to Ardena

As a leading Contract Development and Manufacturing Organization (CDMO), 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, clinical logistics, bioanalytical services, 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 Somerset, New Jersey (the US). 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.

If you are ready to take on new opportunities, work alongside industry experts, and contribute to the future of medicine, Ardena is the place for you.
 

For the Ardena Business Unit based in Oss, we are looking for a (Sr.) QA Officer – Quality systems

YOUR ROLE

You will be the central SME and point of contact for the Ardena Oss site regarding Quality systems, including the electronic Quality Management System (Master Control), document control and training management. You will work within a GMP environment to facilitate and guide compliance in Quality systems across the site.

You adhere to procedures, are consistent with emerging/existing corporate & regulatory guidelines and contribute to continuous improvement through leveraging the QMS architecture, assuring product quality and safety.

YOUR KEY RESPONSIBILITIES

• Local Master Control Subject Matter Expert (SME)/ Point of contact for day to day user questions for the Ardena Oss site
• Day to day Master Control user management, including management of training
• Providing Quality system related trainings (e.g. Master Control new user training)
• General system management and keeping track of metrics, (pro-)actively flagging issues to the appropriate parties
• Management of document control / Document control SME
• Facilitating the annual review of the Internal Inspections risk assessment and creating the Internal Inspection plan accordingly
• Advising, facilitating, and supporting compliance with Quality systems across all departments
• You will report to the Head of QA
• You feel comfortable in a dynamic and changing environment
• You are expected to be on site for the above activities, especially the first period during introductions.
  

YOUR PROFILE 

• At least a Bachelor’s degree, preferably with pharmaceutical, chemical or other relevant training
• At least 5 years relevant experience in the pharmaceutical industry. Experience in Quality Assurance is a plus.
• Pragmatic attitude
• Afinity with computer systems
• Experience with electronic QMS systems is a plus, especially hands-on experience with Master Control
• You like to learn and develop yourself and the people around you
• You are flexible and pragmatic, a problem solver, pro-active, a team player and able to work under pressure
• You are stress resistant
• You have good communication skills and are fluent in both Dutch & English (written as well as spoken)                                                                                                                                                                 

 WHAT WE OFFER

At Ardena, we recognize that our people drive our success. We offer:

✔ A competitive salary with a tailor-made benefits package, including: option for extra leave, bonus plan, great pension plan.
✔ Flexible working hours and 30 days of paid holiday per year
✔ A dynamic, international work environment with career growth opportunities
✔ Access to Ardena Academy, our internal learning platform for professional development
✔ A chance to contribute to groundbreaking drug development projects that make a real impact

HOW TO APPLY

Want to know more? Contact Jeroen Geeven at jeroen.geeven@ardena.com. 

Ready to start your career path with Ardena? Click the application button and join us in shaping the future of drug development!