Head of Quality Department
Уровень дохода не указанОпыт работы: 3–6 лет
Полная занятость
График: 5/2
Рабочие часы: 8
Формат работы: гибрид
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.
- 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.
- Supplementary medical insurance and covered mobile after probation period
- hybrid model of work after probation period
Навыки
- Английский язык
- Контроль качества
- Quality Management
- Quality Control
- ISO 9001
- GMP
- FDA
- ICH GCP
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Адрес
Санкт-Петербург, Ковенский переулок, 5
Вакансия опубликована 10 декабря 2024 в Санкт-Петербурге