Director of Quality Assurance and Compliance

il y a 4 jours


Paris, Île-de-France Biorasi Temps plein
Quality Assurance and Compliance Expert

Biorasi is a leading clinical research organization that values excellence in quality and compliance. We are seeking a highly skilled and experienced Quality Assurance and Compliance expert to join our team.

Key Responsibilities:

  • Develop and implement GCP Quality Systems and SOPs
  • Provide QA oversight and auditing of eTMFs
  • Design and implement a risk-based clinical Quality Assurance management system in partnership with Clinical Operations, Regulatory, and Pharmacovigilance teams
  • Identify QA and compliance related issues and implement solutions to ensure timelines are maintained
  • Establish metrics and report the state of GCP Quality and compliance of clinical trials to senior management
  • Ensure Biorasi quality systems, processes, and procedures are compliant with applicable regulations and ICH guidelines
  • Oversee the planning and conduct of internal, investigator, and vendor Quality Assurance audits
  • Manage the administration of Quality Assurance files and the control of central files

Requirements:

  • Master's degree in biomedical sciences or related scientific discipline
  • ~10+ years in drug development or clinical research within the pharmaceutical industry or CRO with at least three years in quality assurance, quality management, or clinical safety related area of responsibility
  • Proficient with Microsoft Office tools

About Biorasi:

Biorasi is an award-winning, customer-focused, full-service clinical research organization that capitalizes on your strengths while encouraging work-life balance. We are committed to excellence in quality and compliance, and we are seeking a highly skilled and experienced Quality Assurance and Compliance expert to join our team.



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