GCP Quality Assurance Manager

Position Summary

  • Ensuring that the pharmaceutical Quality Management System of SOTIO a.s. is in compliance with applicable regulatory requirements and established industry standards.
  • Providing Good Clinical Practise expertise support to functional departments and teams.
  • Line management and coaching of QA employees (if applicable)

Key Activities and Responsibilities

  • Develop, coordinate and supervise QA processes particularly in the area of Good Clinical Practise (controlled standards and training, audit and vendor management, risk control and mitigation, deviation and CAPA systems, change management etc.).
  • Maintain overview of regulatory requirements and industry standards for quality assurance in clinical trials.
  • Coordinate compliance training for new and current employees.
  • Support the selection, monitoring and auditing of suppliers/vendors.
  • Auditing of clinical trial investigational sites in collaboration with the project teams.
  • Provide expertise and leadership in quality assurance related projects.
  • Act as primary contact for external auditors and regulators during GCP audits/inspection.
  • Cooperate with other departments to ensure consistency of quality activities and processes.

Competences, Skills and Qualification

  • Bachelor or MS degree
  • Thorough understanding of clinical trials conduct
  • Previous Quality Assurance experience required
  • Investigational Site auditing experience preferred
  • Dynamic, team and goal-oriented personality
  • Excellent communication, interpersonal and organizational skills
  • Good time management
  • Fluent English (written and spoken)
  • Regulatory inspections awareness and readiness
  • Good Clinical Practice expertise
  • SOP writing experience
  • Good knowledge of MS-Office
  • Internet communication and information searching

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