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Gcp Quality Assurance Manager
vor 3 Monaten
Play a crucial role in this state-of-the-art, well-equipped early-phase clinical trials centre, dedicated to driving innovation in the clinical research sector.
Showcase your expertise in GCP quality complianceLead and develop team - drive improvements in quality and compliance strategies.5-day on-site position in Sydney East, offering competitive packaging with salary sacrificeAn exciting opportunity has arisen for a Quality Assurance Manager to join this world-class Clinical Research Centre with a state-of-the-art bedded facility to take charge of the overall quality management, including site audit preparations and responses, QMS, CAPA, and managing quality records and deviations while supervising the Quality Team of 3.
You will also play a crucial role in overseeing the research governance, ethics, and regulation aspects ensuring clinical studies meet regulatory and internal compliance requirements and supporting the team in GCP training, sharing regular education on regulations to uphold the operational compliance and quality management of early phase oncology clinical trial studies.
In this leadership role, you will work closely with Clinical Trials Project Managers, Laboratory and Pharmacy teams to lead and drive a culture of quality compliance mindset, problem resolutions, identifying gaps in processes and implementing efficient quality measures.
Ideally, we are looking for you to bring:
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 showcase proactiveness in managing complex issues.A degree in life sciences or a related field.To be considered for this role you must be based in Sydney, Australia, and work on-site 5 days a week.
This role offers a competitive salary package with salary sacrifice of up to $16k per year, meaning you can expense a portion of your salary on expenses to increase take-home pay.
Please contact Christina Ntoka on for a confidential discussion.
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