Senior Quality Assurance Associate

Join a state-of-the-art, well-equipped early phase Clinical Trials Centre, dedicated to driving innovation in the clinical research sector. 

• Showcase your commitment to quality compliance to uphold the highest standards in clinical research.
• Supportive and adaptive environment where you have solid team support
• 5 day on-site position, offering competitive packaging with salary sacrifice

We are seeking a Senior Quality Associate to join this world class clinical research centre with State-of-the-art bedded facility to play a crucial role in upholding the operational compliance and quality management of early phase oncology clinical trial studies.

As a Senior Quality Associate, you will contribute to the overall operational compliance including the oversights and maintenance of our Quality Management Systems (QMS), document preparation and coordination of audits and inspections whilst responsible for addressing complex site queries and the analysis and management of corrective and preventative actions (CAPA).

Working closely with our Quality Assurance Manager, you will have the opportunity to showcase your expertise in clinical research best practices and support the development of a structured internal training program to strengthen regulatory and GCP compliance awareness across the clinical trial centre.

You will lead by example in fostering a culture of quality compliance and continuous improvement with a dynamic and collaborative team and uphold regulatory requirements and internal standards. Ideally, we are looking for you to bring:

• 3 years experience within a Quality Assurance role in a pharmaceutical, biotechnology, and/or CRO environment. Investigational Site experience is preferred.
• High level of Quality and compliance mindset and sound knowledge of GCP and other compliance audits and inspections
• Sound experience with CAPA management, and conducting Root Cause Analysis
• Experience in developing and implementing internal learning programs, driving GCP compliance and auditing experience
• Adaptable and flexible, ability to maintain positive relationships with cross-functional stakeholders in a changing environment.
• Strong problem handling skills and showcase proactiveness in managing complex issues

To be considered for this role you must be based in Sydney, Australia, and work on-site 5 days a week. This role offers competitive salary package with salary sacrifice up to $16k per year, this means you can expense a portion of your salary on expenses to increase take-home pay. 

Please contact Christina Ntoka on 02 9431 2*** for a confidential discussion, we're always interested to hear from talented and engaging people like you. Get in touch and tell us about yourself.