Not specified (inferred to include potential global travel up to 50%)
Clinical quality assurance experience
Gcp regulations knowledge ich e6
Global audit execution capability
CSL Seqirus is seeking a CQA Auditor to execute global audit plans within their Research & Development Quality audit program, ensuring compliance with clinical trial standards and regulations. The ideal candidate should have a strong background in quality assurance within GCP-regulated environments and excellent communication skills for collaboration with various stakeholders
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 vaccine prevention and values inclusion and belonging as core to its mission.
Matching Summary
Match Score: 85
CSL Seqirus is seeking a CQA Auditor to execute global audit plans within their Research & Development Quality audit program, ensuring compliance with clinical trial standards and regulations. The ideal candidate should have a strong background in quality assurance within GCP-regulated environments and excellent communication skills for collaboration with various stakeholders.
Skills & Requirements
Must-have
Clinical Quality Assurance experience
GCP regulations knowledge ICH E6
Global audit execution capability
Risk categorization and CAPA development
Trend analysis for non-compliance
Nice-to-have
Collaborative stakeholder management skills
Ability to work with limited supervision
Strong analytical problem-solving abilities
Experience with multinational clinical teams
Key Requirements
BS degree in biological science or related discipline
Quality Assurance experience within GCP-regulated environment
Experience in clinical audit and inspection management
Ability to manage schedule including up to 50% global travel