Quality Director

About Ardena

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 our Quality department, based in Mariakerke (Gent, Belgium), we are looking for a

QUALITY DIRECTOR

YOUR KEY RESPONSIBILITIES

As Quality Director, you are the central point of contact for all Quality\-related matters within our organization. You will have a broad and varied strategic and operational role:

• Developing and implementing quality policies and procedures, particularly those of IMPs.


• Leading the Quality department (including the engineering subgroup) and ensuring the necessary training and development of employees.


• Supervising and actively participating in internal and external audits where necessary and ensuring compliance with regulations.


• Analysing quality data and reporting findings to the Management Team.


• Collaborating with the GMP Production department, R\&D (formulation), and the analytical department to resolve quality issues and implement improvements.


• Working closely with corporate functions to shape strategy and processes for the Ghent site within the Ardena group.


• Reconciling business objectives with legal quality requirements in the pharmaceutical industry.


• Play a pivotal role in shaping how Ardena leverages AI to elevate its global quality systems and ways of working. You will act as a visionary leader, ensuring that AI is thoughtfully, responsibly, and effectively embedded across our quality processes, both locally and globally. You are part of the local Management Team and report to the Chief Quality Officer.

• You have at least 7 years of experience in Quality, with leadership experience.


• You hold a master's degree in Pharmaceutical Sciences


• You have a thorough knowledge of GMP regulations


• You are a 'people person' with strong analytical and strategic skills and are solution\-oriented \& hands\-on.


• You are strong in communication and can advise and support both employees and managers.


• You have an open mindset and radiate calm and confidence.


• You can express yourself fluently in English.


• You also have a well\-developed business mindset.

An attractive and tailor\-made remuneration package, including extra\-legal benefits such as:

• An attractive salary system including relevant extra\-legal benefits (meal and eco vouchers, group and hospitalization insurance, company car, etc.).


• Flexible working hours \+ option to work partially from home


• 32 days of vacation per year.


• Opportunity to develop your skills in a dynamic and rapidly growing company with an international customer portfolio.


• A dynamic working environment with nice colleagues


• Open straightforward but also caring culture


• We love creative thinking and pro\-activeness


• We are true to our values

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