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 Senior Quality Officer

WHAT YOU WILL WORK ON

Senior Quality Officer

YOUR ROLE

The Senior Quality Officer ensures that GMP manufacturing activities on the shop floor and in the analytical laboratory, are executed in accordance with cGMP requirements. He/she adheres to the Quality Management System (QMS), is consistent with emerging/existing corporate & regulatory guidelines and contributes to continuous improvement through leveraging the QMS architecture, assuring product quality and safety.

YOUR KEY RESPONSIBILITIES

• The QA representative in a global customer project. You will work together with the customer, the production team and your colleagues in the QA team in Oss
• Participate in audits from customer and authorities.
• Executing internal and external QA inspections.
• Establish and maintain quality requirements for GMP manufacturing.
• Advising, facilitating, and supporting all phases of manufacturing/analytical batch documentation development.
• Review and approve specifications, methods, batch documentation and risk assessments.
• Release of product.
• Review, approve and follow up on deviations, change controls, CAPAs and OOS results.
• Write, review, and approve instructions.
• You feel comfortable in a dynamic and changing environment.
• You can prioritize, and you are stress-resistant
• No personnel responsibilities are included in the role
• You are expected to be on site in Oss for the above activities.

YOUR PROFILE 

• At least a Bachelor’s degree, with pharmaceutical, chemical or other relevant training.
• At least 5 years relevant experience in the pharmaceutical industry.
• Experience and good knowledge of quality management systems such as cGMP, ISO.
• Experience in providing GMP trainings.
• Pragmatic attitude.
• Hands-on mentality
• Able to apply phase-appropriate GMP principles in the process development trajectory.
• You like to learn and develop yourself
• You are flexible, a problem solver and a team player
• You have an analytical mindset and you are stress resistant
• You have good communication skills and are fluent in Dutch and English (written as well as spoken).
• You're well-equipped with a creative mindset and pro-active attitude    
• Experience with Nano/Biotech is preferred                                                                                                                                                            

 WHAT WE OFFER

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

✔ A competitive salary with a tailor-made benefits package
✔ 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 or call +31(0)6 51699242.

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