Quality Assurance Manager
Il y a 7 mois
**QA Manager**
As a global Research Organization to the biopharmaceutical industry, **CellCarta (formerly Caprion - HistoGeneX)** provides access to a broad offering of biomarker platforms and services. We partner with our clients to address the most complex scientific testing needs, delivering customized biomarker testing solutions to further the limitless potential of precision medicine.
We offer our services on a global scale through our laboratories in USA, Canada, Belgium, China and Australia. Combining expertise in histopathology, immune monitoring, proteomics, genomics and sample logistics, we support pharmaceutical and biotechnology companies in the research and development of innovative new medicines for the treatment of cancer and immune diseases. Working under stringent quality and regulatory requirements, we strive to make a difference in the future treatment options offered to patients.
CellCarta leverages its strong expertise in cancer to support the entire spectrum of biomarker services including biomarker discovery in the research phase, tumor profiling and biomarker monitoring in clinical studies and companion diagnostics registration studies, patient diagnostics and development of new techniques and tests for tumor analysis and prediction of treatment response. The company bridges the gap between research, clinical studies and diagnostics.
We are currently recruiting**:QA Manager**
Department**:Quality Assurance**
**Based in**
Wirlijk, Antwerp (Belgium)
**Purpose of the function**
The Quality Assurance Manager works as member of the Quality Assurance team ensuring that all activities are performed in accordance with GCP, GCLP, CAP/CLIA, ISO15189 and ISO 13485 standards.
**Major responsibilities**
The QA Manager has in-depth knowledge in QMS systems and is responsible for the following:
- Define and implement quality procedures in conjunction with operating staff
- Maintain and improve existing quality processes to ensure continuously appropriate/compliant operation
- Perform QA review of documentation in the Quality Management System
- Perform internal audits
- Provide assistance for sponsor audits and regulatory inspections (preparation, hosting and follow-up actions)
- Review and approve non-conformities, deviations and complaints and support root cause investigations in operations
- Review and approve Corrective and Preventive Actions
- Review and approve changes with impact to the QMS
- Work with relevant departments to ensure timely closure of quality action plans
- Actively contribute to continuous improvement and quality awareness initiatives
- Perform QA related training
- May lead QMS related projects
- Act as a resource for colleagues with less experience
- Contribute to the preparation of management reviews
- Assist in the follow-up of KPI’s and investigate trends
- Contribute actively in the risk management activities of the company
**Qualifications and skills**
- Bachelors’ degree preferred, or equivalent by experience (preferably Biology, Biomedical Sciences, Bioengineering, Pharmaceutical Sciences, Biochemistry) with a minimum of 3 years of experience in a quality assurance role.
- Experience to work according to quality standards (such as ISO 15189, ISO 13485, CAP/CLIA)
- Attention to detail
- Good Communication skills (verbal and written)
- Analytical mind
- Having diplomatic capabilities
- Team-player
**Reporting**
The QA Manager reports to the Site Head QA or a Senior QA Manager.
**What can we offer**
- A dynamic and rapidly changing global environment allowing personal growth
- A company that is fit for the future
- A competitive salary and benefits
- A great team you can work with
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