Job Description

At  Ardena, we’re helping shape the future of medicine. Our teams work on the development of innovative and complex therapies that can improve the lives of patients around the world. 

As a global Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO), Ardena partners with pharmaceutical and biotech companies to turn scientific ideas into real treatments. From early development to manufacturing and regulatory support, we help bring new medicines to market faster and with the highest quality standards. 

With more than 750 colleagues across Europe and the United States, Ardena offers expertise in drug substance and drug product development, manufacturing, bioanalytical services, clinical logistics, fill & finish, and CMC regulatory support. 

But what truly makes Ardena special is our people. We are a science-driven and people-focused company where collaboration, innovation, and curiosity are encouraged. 

We offer an international environment where you can learn, take initiative, and grow your career across teams, functions, and locations. Our way of working is guided by our CARE values: Communicative, Accountable, Reliable, and Excellent. These values shape how we collaborate, solve challenges, and support each other every day. 

At Ardena, you’re not just building your career — you’re helping build the future of medicine. 

For the Ardena Business Unit Drug Product Development and Manufacturing (DDM) based in Mariakerke (Gent, Belgium), we are looking for a

QUALIFIED PERSON

YOUR KEY ROLE

Ardena Gent guides a worldwide portfolio of customers through the processes of formulation and analytical development, preparation of regulatory dossiers and the manufacturing and labeling of early-phase clinical materials according to GMP appropriate standards.

The analytical laboratory plays a key role in the development and validation of analytical methods to characterize drugs and to perform quality control testing on incoming raw materials and on the finished clinical materials.

You act as the Qualified Person for the assigned projects:

• you certify the batches of investigation medicinal products (IMPs) according the applicable legislation

YOUR KEY RESPONSIBILITIES

• Reviews the documents (including reference and retention samples) for completeness and compliance. 
• Ensures the Product Specification File (PSF) is up to date. 
• Evaluates deviations, changes and out-of-specification results related to the manufactured IMP subject to the QP certification. 
• Approves the yearly internal audit plan as well as the internal audit reports (as applicable by the audit plan) and attends the internal audits as required. 
• Assists during (internal) audits and where required during meetings with Contract Giver. 
• Approves the yearly contractor audit plan and the contractor audit reports. 
• Approves Multi-Party Quality Agreements with Contract Givers. 
• Attends regulatory inspections and is involved in the communication with the authorities.  
• Is involved directly in all communications related to the recall process and complaint handling. 
• Keeps up to date with changes in GMP legislation. 
• Reviews and approves Technical Quality Agreement. 
• Writes procedural documents related to the batch certification. 
• Reviews and/or approves the procedural documents with potential direct impact on batch certification. 
• During technical or strategical meetings on GMP manufacturing, acts as a reference point concerning the possible impact on batch certification. 

YOUR PROFILE

• You have a Master of Science degree in Pharmaceutical Sciences.
• You are registered or qualified to apply for Qualified Person by the Federal Agency for Medicines and Health Products (FAMHP).
• You have knowledge of GMP quality system and regulatory requirements (Eurdralex, ICH).
• 5y QP experience in pharma.
• You are solution driven keeping timelines and budget in mind.
• You are continuously looking for improvement.
• You have strong communication skills, able to listen and analyse a quality issue and explaining the proposed solution in an accurate manner.
• You can provide QA support across multiple projects, and enjoy contributing to project teams.
• You are a team player.
• You are familiar with MS Office.
• You show flexibility and you are open-minded and change oriented (always looking for ways to improve).
• AI savviness is a must

WHAT WE OFFER

• An attractive remuneration package with extra-legal benefits such as meal vouchers and group/hospitalization insurance
• A true learning environment where you will have the ability to grow your skills
• A rapidly developing and growing international company with an attractive services, product and customer portfolio
• A dynamic working environment with nice colleagues
• Open straightforward but also caring culture
• We are true to our values
• An attractive remuneration package including 32 holidays
• Flexible working hours