GCP Quality Assurance Manager

4 weeks ago

Sydney, New South Wales, Australia On Q Recruitment Full time
Quality Assurance Manager

On Q Recruitment is seeking a highly skilled Quality Assurance Manager to join our client's world-class Clinical Research Centre in Sydney East. As a key member of the team, you will play a crucial role in driving innovation in the clinical research sector.

Key Responsibilities:
  • Lead and develop a team to drive improvements in quality and compliance strategies.
  • Manage quality records and deviations, and supervise a Quality Team of 3.
  • Oversee research governance, ethics, and regulation aspects to ensure clinical studies meet regulatory and internal compliance requirements.
  • Support the team in GCP training and share regular education on regulations to uphold operational compliance and quality management.
Requirements:
  • 5 years' experience in a quality assurance role within pharmaceutical, biotechnology, or CRO environment. Phase 1 clinical trial experience is preferred.
  • Comprehensive knowledge of GCP, compliance audits, and other regulatory requirements.
  • Sound experience with CAPA management and conducting root cause analysis.
  • Strong problem-handling skills and proactive approach to managing complex issues.
  • A degree in life sciences or a related field.
What We Offer:

A competitive salary package with salary sacrifice of up to $16k per year, offering a 5-day on-site position in Sydney East. If you are a motivated and experienced Quality Assurance professional looking for a new challenge, please contact Christina Ntoka for a confidential discussion.

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