Обязанности:
Job responsibilities: Manage and supervise Quality Assurance Department activities. Supervise and evaluate department personnel. Allocate tasks to department employees. Report to the Company management regarding department status and Сompany quality issues. Manage QMS including documents preparation, review, and approval. Establish and monitor key performance indicators (KPIs) to assess the effectiveness of quality management system. Identify corporate potential risks; develop risk mitigation strategies and process improvement plans to address identified risks and enhance the overall quality. Perform internal audits of all Company units and groups, report findings to the Company management and advice on performance improvement. Perform project audits of investigational sites and study files (TMF/ DMF/ BSF). Perform vendor audits, report findings to the Company management and to relevant Company personnel. Host customer audits and regulatory inspections; act as a contact point for client companies. Review study-specific documentation (CSP, CSR, IB, ICF, DMP, DMR, project-specific plans, etc.). Consult other employees on quality issues. Collaborate closely with other departments to ensure alignment and integration of quality processes. Prepare and conduct initial and ongoing trainings in cooperation with relevant departments. Collaborate closely with other departments to ensure alignment and integration of quality processes. Continuously review the processes within Company in order to find ways to improve them. Continuously review QMS to ensure Company continuing suitability, adequacy, effectiveness and alignments with Company strategic direction. Perform other activities as requested by the Company management. Requirements: University Degree. At least 5 years of experience in clinical research, of which at least 2 years in quality assurance. Experience working with electronic data capture (EDC) systems, clinical trial management systems (CTMS), and other clinical research technologies. Knowledge of FDA, EMA, ICH, and other global regulatory requirements applicable to clinical research. At least Upper-Intermediate English, written and spoken Strong managerial skills. Demonstrated problem-solving and analytical capabilities. Ability to establish credibility and be decisive. Well-developed interpersonal and communication skills. Conditions: Supplementary medical insurance and covered mobile after probation period hybrid model of work after probation periodПохожие вакансии