Our client, a Belgian pharmaceutical company, is recruiting a Quality Assurance Manager to be located in Brussels, Belgium. The company is dedicated to the research, development and production of innovative pharmaceutical products using advanced drug delivery solutions for a wide range of therapeutic indications improving patient safety and compliance. Our client performs the complete development of medicines till marketing authorization. The company intends to provide benefits to the patients with new treatment alternatives based on specific galenical development. The role of the Quality Assurance Manager (QAM) is to develop, establish and oversee the QA systems and processes within the clinical research group. S/he will support and work with the clinical study management team and teammates across R&D, laboratory, pharmacovigilance, regulatory and manufacturing.
We have an exciting opportunity for a talented and experienced quality driven manager working close with the clinical research group.
The role of the Quality Assurance Manager (QAM) is to develop, establish and oversee the QA systems and processes within the clinical research group. S/he will support and work with the clinical study management team and teammates across R&D, laboratory, pharmacovigilance, regulatory and manufacturing
Responsibilities & Accountabilities
You manage the QA department, which consists of 2 people, within the clinical research group.
- You get the responsibility to direct and control the installation, maintenance and adherence to appropriate quality system in full compliance with national and international regulatory requirements on clinical research.
- You oversee and develop the quality management system; you coordinate the development, revision, implementation and traceable distribution of quality documents (e.g. SOPs).
- You maintain an up to date and in-depth knowledge of appropriate national and international GCP/GxP legislation and guidelines; and assess the impact to assigned business area processes and procedures.
- You are a reliable source of reference and a leading example for employees seeking council regarding quality issues within the clinical research group.
- You perform GCP audits including but not limited to investigator sites, internal processes and vendors.
- You support deviation identification, reporting and CAPA development. – You assist in readiness preparation and directly support regulatory agency inspection.
- You work closely with clinical study management team to provide expert clinical compliance information, managed identified issues, and support continuous improvement.
- You handle multiple projects and ensure overall and timely completion of tasks. – You generate and provide metrics, status and trend reports.
- You oversee the training needs of the clinical research group and manage the data protection related activities and information (GDPR).
- You represent QA in all operational meetings related to the area of responsibility
Experience, Skills and Knowledge
- Master Degree in Pharmacy, Science, or an engineering discipline or equivalent level of knowledge
- Understanding and hands-on experience of Good Clinical Practice in the pharmaceutical environment.
- Minimum 5 years’ experience in the QA pharmaceutical sector.
- Fluent in French and English.
- Knowledge of European regulatory regulations, GxP and Quality Systems is required.
- Ability to handle audit situations and interaction in a tactful, professional, and effective manner. Ability to lead and facilitate group discussions in a constructive and positive direction.
- Self- organized, pro-active, and solution-oriented
- Proficient in Microsoft Office suite. Access knowledge is an asset.
Our client Core Values
- Internationally active, Belgian owned
- Family culture and atmosphere
We are looking for a colleague/manager working within the clinical research team. The new employee will have a scientific background and will focus on all aspects of quality assurance with his/her team. Bringing team spirit and quality work. The responsible for the quality assurance together with the team.