Ardena is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development, manufacturing, logistics and bioanalytical services.
The Ardena Group is operating from five sites in Europe and one in US.

For the Ardena branch based in Mariakerke (Gent, Belgium), we are looking for a

Quality Assurance Manager / 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 Quality Assurance Manager:

• as a point of contact for the assigned projects:
  • you approve the Technical Quality Agreement
  • you approve the master Batch Record Documentation
  • you are involved is QA processes related to the project
  • you are the person who dissolves in a pragmatic way encountered issues
• as the key function to ensure:
  • correct implementation and management of the quality processes
  • continuous evaluation and optimisation of the processes
  • adequate training of the quality processes to the Ardena Gent group.

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

As quality assurance Manager:

• You are responsible to ensure correct execution of the pharmaceutical quality system.
• You support on building lean and efficient processes, ensuring continuous improvement of the pharmaceutical quality system.
• You are responsible to manages the daily follow-up of non-conformances (deviations, changes, CAPAs, complaints).
• You perform the internal audits.
• You provide (GMP) training to the personnel and approves competences.
• You review and approve initial and periodic qualification/validation documentation and reports of equipment and computerized systems.
• You issue or review procedural documents.
• You report to the Associate Director Quality.

QA/QP Project-related tasks:

• You are involved in a project from the kick-off until batch certification.
• You review and approve master documentation related the assigned project.
• You approve the multi-party quality agreements.
• You ensure that each batch of investigational medicinal product that is manufactured within Ardena Gent has been produced and QC-tested in accordance with the applicable directives and the Investigational Medicinal Product Dossier (IMPD) and/or the Investigational New Drug (IND) Application.
• You certify the produces batches of investigation medicinal products.
• You manage the reference and retention samples.
• You keep the product specification file up to date.
• You attend regulatory inspections and are involved in the communication with the authorities.
• You are directly involved in all communications related to the recall process and complaint handling.

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).
• 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 analyse 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 are a team player.
• You are familiar with MS Office.

WHAT WE OFFER

• 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