Auditor - Cqa

CSL Seqirus

Not specified (assumed to be hybrid due to the mention of global travel).
Clinical quality assurance experience
Gcp regulations knowledge ich e6
External audit execution skills
CSL Seqirus is seeking an experienced CQA Auditor to execute global audits of clinical trials, ensuring compliance with regulatory standards and improving operational resilience. The ideal candidate will possess a strong background in Quality Assurance within GCP-regulated environments, along with excellent communication and analytical skills

Job Summary

  • This role serves as a CQA Auditor responsible for executing the global audit plan to ensure the accuracy of clinical trial data.
  • The position requires identifying findings and non-compliance trends that could impact the integrity of clinical research across various stakeholders.
  • CSL Seqirus is a major contributor to influenza prevention globally with state-of-the-art production facilities in the U.S., U.K., and Australia.

Matching Summary

Match Score: 85

CSL Seqirus is seeking an experienced CQA Auditor to execute global audits of clinical trials, ensuring compliance with regulatory standards and improving operational resilience. The ideal candidate will possess a strong background in Quality Assurance within GCP-regulated environments, along with excellent communication and analytical skills.

Skills & Requirements

Must-have

  • Clinical Quality Assurance experience
  • GCP regulations knowledge ICH E6
  • External audit execution skills
  • CAPA development and risk categorization
  • Trend analysis for non-compliance

Nice-to-have

  • Collaborative stakeholder engagement
  • Global travel capability up to 50%
  • SOP improvement initiatives
  • Multinational team communication

Key Requirements

  • BS degree in biological science or related discipline
  • Quality Assurance experience in GCP-regulated environment
  • Experience in clinical audit and inspection management

Work Rights

Not specified

Tailored Resume

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