Auditor - Cqa

CSL Behring

Not specified (assumed hybrid based on responsibilities and travel requirements).
Clinical audit execution experience
Gcp regulatory knowledge ich e6
Risk categorization and capa development
CSL Behring is seeking a CQA Auditor to execute a global audit plan within their Research & Development Quality audit program, focusing on compliance and data integrity in clinical trials. The ideal candidate will possess quality assurance experience, audit expertise, and strong communication skills to collaborate with stakeholders in the clinical environment. This role offers the opportunity to contribute to life-saving therapies while being part of a diverse and inclusive culture

Job Summary

  • This role serves as a CQA Auditor responsible for executing the global audit plan to ensure the accuracy of clinical trial data and compliance with legal standards.
  • The position requires identifying non-compliance trends and systematic risks within the Clinical discipline to communicate findings to line management and ensure trial robustness.
  • CSL Behring is a global biotherapeutics leader driven by a promise to save lives, offering a culture of inclusion and belonging at its core.

Matching Summary

Match Score: 85

CSL Behring is seeking a CQA Auditor to execute a global audit plan within their Research & Development Quality audit program, focusing on compliance and data integrity in clinical trials. The ideal candidate will possess quality assurance experience, audit expertise, and strong communication skills to collaborate with stakeholders in the clinical environment. This role offers the opportunity to contribute to life-saving therapies while being part of a diverse and inclusive culture.

Skills & Requirements

Must-have

  • Clinical audit execution experience
  • GCP regulatory knowledge ICH E6
  • Risk categorization and CAPA development
  • Trend analysis for non-compliance
  • Global travel up to 50%

Nice-to-have

  • Excellent interpersonal negotiation skills
  • Collaborative work with multinational teams
  • Strong analytical problem-solving abilities
  • Experience with CROs and IRBs

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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