About us
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 Drug Product Development and Manufacturing (DDM) based in Mariakerke (Gent, Belgium), we are looking for a
(JUNIOR) QA MANAGER
WHAT YOU WILL WORK ON
Ardena Gent guides a worldwide portfolio of customers through the processes of formulation and analytical development and the manufacturing and labeling of early-phase clinical materials according to GMP appropriate standards.
The Quality Assurance group plays a key role in ensuring manufacturing of investigation medicinal products (IMPs), according GMP, with respect of appropriate designed workflows and processes.
YOUR KEY RESPONSIBILITIES
The Quality Assurance Manager is responsible for day-to-day implementation of the Pharmaceutical Quality System in the organization.
* Drafts and keeps up to date the procedures and process flows related to non- sterile as well as sterile manufacturing.
* Provides or supports in training of the personnel for what concerns the Quality processes and GMP awareness.
* Responsible for the daily follow up of the pharmaceutical management system: deviations, changes, CAPAs, complaints, supplier qualification, logbooks, equipment qualification, destructions, shipments, reference and retention samples.
* Assists during contractor audits, contract giver audits and performs internal audits.
* Assists the Qualified Person in the preparation of the batch certifications.
* Reviews and approves master and executed (project-related) documents (e.g. Batch Record Documentation, Incoming Material Records).
YOUR PROFILE LOOKS LIKE/ RESEMBLES
* You have a Master degree in Life Sciences (Pharmaceutical Sciences, Biomedical Sciences, (Bio)Chemistry).
* You have knowledge of GMP quality system and regulatory requirements.
* A first experience in Quality Assurance in pharma is a plus.
* 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 analyze a quality issue and explaining the proposed solution in an accurate manner.
* You are able to manage the QA support on multiple projects, and like participating in project teams.
* You can express yourself fluently in English.
WHAT WE OFFER
An attractive and tailor-made remuneration package including extra-legal benefits such as meal- and eco vouchers, group- and hospitalization insurance, compensation if you come to work by bike, option for bike lease, etc.
On top of that we offer
* A true learning environment where you will have the ability to grow your skills
* A rapidly International developing and growing company with an interesting services, product and customer portfolio
* A dynamic working environment with nice colleagues
* Open straightforward but also caring culture
* We are true to our values
* Flexible working hours
* 32 days holiday a year