Head of Quality Department

Уровень дохода не указан

Опыт работы: 3–6 лет

Полная занятость

График: 5/2

Рабочие часы: 8

Формат работы: гибрид

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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 period

Навыки

  • Английский язык
  • Контроль качества
  • Quality Management
  • Quality Control
  • ISO 9001
  • GMP
  • FDA
  • ICH GCP

Адрес

Санкт-Петербург, Ковенский переулок, 5

Вакансия опубликована 10 декабря 2024 в Санкт-Петербурге

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