QA Associate

1 week ago

Melbourne, Victoria, Australia IDT Australia Limited Full time
About Us

IDT Australia is an ASX-listed Contract Development and Manufacturing Organisation (CDMO) providing globally recognised pharmaceutical development and GMP manufacturing services. With a strong focus on cancer and mental health therapies, we support the development of novel medicines for clinical trials through R&D, process scale-up, and sterile manufacturing. Our facilities are TGA and FDA accredited, and we operate uniquely within Australia's pharmaceutical landscape.

About The Role

We are seeking a highly skilled and strategically minded QA Associate to join our Quality team. This role is not a standard QA position—it is designed for professionals who bring deep expertise in organisational analysis, quality systems, and change facilitation within a GMP-critical environment. The QA Associate plays a pivotal role in supporting IDT Australia's commitment to delivering novel medicines for clinical trials, particularly in the areas of cancer and mental health therapies.

Skills & Experience Required

We are seeking a candidate with advanced expertise in organisational systems and quality frameworks within a GMP-regulated pharmaceutical environment. The ideal applicant will demonstrate:

  • Proven experience in change management facilitation, particularly in implementing quality systems and continuous improvement initiatives.
  • Strong capabilities in quality auditing, including vendor assurance, documentation review, and regulatory compliance.
  • Experience in skills auditing and workforce capability analysis to support operational excellence.
  • Proficiency in industry analysis, with the ability to evaluate and optimise manufacturing and quality processes.
  • Exceptional analytical and problem-solving skills, with a track record of contributing to successful organisational improvement initiatives.
  • Advanced communication and stakeholder engagement skills, with the ability to influence cross-functional teams and drive strategic outcomes.
  • Project management experience in complex pharmaceutical environments, including sterile manufacturing and novel therapy development.
Minimum Requirements
  • Tertiary qualifications in Pharmacy, Science, Engineering, or a related discipline.
  • Minimum 5 years' experience in a quality, compliance, or organisational improvement role within the pharmaceutical or life sciences sector.
  • Demonstrated ability to work autonomously and lead quality initiatives across multiple projects.

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