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Location: Antwerp, Flemish Region, Belgium | Type: Remote | Country: BEThe Quality Assurance Manager is responsible for performing quality assurance activities as defined in the quality management system, ensuring compliance with applicable standards and regulations. SummaryThis role is an individual contributor position within a global quality organization and has no direct reports. The position requires effective collaboration with cross-functional teams to support compliance and quality objectives. ResponsibilitiesClient Audits & Regulatory InspectionsLead client audits and regulatory inspections, including preparation, hosting, coordination, response management and follow-up activitiesPresent and explain the Quality Management System (QMS) and key operational processesCoordinate and provide responses to auditor and inspector inquiries in collaboration with subject matter expertsCoordinate the investigation, root cause analysis, CAPA development and timely resolution of audit findingsQuality System Oversight & DocumentationReview and approve controlled documents and records, to ensure accuracy, completeness and compliance with internal procedures and regulatory requirementsReview and approve quality events, deviations, complaints, investigations and CAPAsFacilitate, review and approve change control activitiesSupport Quality Management System processes, quality processes training, internal audits, supplier qualification and oversight, computerized system validation, equipment lifecycle management, quality metrics, risk management and continuous improvement initiativesEducationBachelor’s degree in a scientific discipline, or equivalent by experienceMain RequirementsMinimum 3 years of Quality Assurance experience in a regulated environment, preferably within the biotechnology, pharmaceutical, CRO, medical laboratory or medical device industry, with exposure to GCP, GCLP, CAP/CLIA, ISO 15189, ISO 13485, and applicable regulatory requirementsAttention to detailGood knowledge, orally and written of EnglishGood communication skills (verbal and written)Good analytical thinking skillsAble to establish work priorities and meet deadlinesApplies risk-based thinkingProfessional and positive attitude, take initiative and act accountableWorking ConditionsFull-time position with a hybrid work schedule requiring a minimum of three days onsite per weekAbout CellCartaCellCarta is a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. Leveraging its integrated analytical platforms in immunology, histopathology, proteomics, and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development cycle, from discovery to late-stage clinical trials. The Company operates globally with facilities located in Canada, USA, Belgium, Australia, and China. Joining CellCarta means working with dedicated professionals who are focused on achieving our mission of impacting the future of patient therapy. We make a difference in the lives of patients around the world! Join us as we make an impact on patient therapy!The information collected to review your application will be processed by the human resources services of CellCarta Biosciences Inc. and its affiliates (collectively, “C Powered by JazzHR 324MGDiLro
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