Quality Assurance 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 a Quality Assurance Manager
Department: Quality Assurance
Based in
Wilrijk, Antwerp (Belgium)
Function
The QA Manager works as member of the Quality Assurance team, ensuring that all activities are performed in accordance with GCP, GCLP, CAP/CLIA and ISO13485. Reports to Director QA Logistics Division.
Major Responsibilities
• Managing the day to day activities of the QA and QC personnel
• Providing quality service and decisions to the operational functions
• Providing oversight of all QA documentation
• Ensuring timelines for QA activities are met
• Managing suppliers and vendors, including completion and review of vendor questionnaires and audits as required, periodic vendor review
• Managing customer/sponsor audits, audit preparation, host auditor, and manage related CAPAs
• Managing customer requests related to the quality system
• Oversee the quality management system
• Assisting QA/QC with inspecting documents, labels, kits, electronic manifests and other study related materials to ensure that each meets the exact specifications outlined by the sponsor and/or the SOW.
• Ensuring that records are kept of all checking, analyzing, inspecting and reviewing. Ensuring that any non-conformities found are documented and investigated.
• Working with IT department to develop tools to improve the quality system
• As a member of the management team, participate in business development, strategy, and operational effectiveness.
Background
• Bachelor or Master Degree in life sciences with preferably 3 years of experience in a quality assurance role in a laboratory or an IVD manufacturing environment
• Advanced knowledge, orally and in writing of English, knowledge of Dutch and French is a plus
• Excellent organizational skills
• Dynamic personality, a true team player with good interpersonal skills
• Analytical thinker with a process-oriented mindset
• Ability to work independently
• Good documentation skills (accurate, attention to details)
• Experience related to quality and regulatory aspects of in vitro diagnostic devices (ISO13485, IVDD, IVDR and/or FDA IDE and PMA regulations) is an advantage
• Willingness to travel
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