
Quality Assurance Expert
1 day ago
As a Quality Assurance Expert, you will lead daily vendor qualification operations within our QA team. This includes overseeing vendor selection, assessments, and qualifications, as well as acting as a subject matter expert in internal forums and vendor-related meetings.
- Manage daily vendor qualification operations;
- Oversee vendor selection, assessments, and qualifications;
- Act as subject matter expert in internal forums and vendor-related meetings;
- Build strong relationships with internal teams and external partners to support vendor use and management;
- Contribute to the development of audit schedules, quality metrics, and reports;
- Drive process improvement by reviewing and updating procedural documentation;
- Support the strategic planning of vendor assurance initiatives;
- Perform additional responsibilities as assigned.
You will also contribute to broader QA activities, including delivering compliance advice, conducting internal and external audits, supporting sponsor audits and inspections, and reviewing and improving QA processes.
- Deliver compliance advice;
- Conduct internal and external audits;
- Support sponsor audits and inspections;
- Review and improve QA processes;
- Perform additional responsibilities as assigned.
To be successful in this role, we are looking for candidates with:
- At least 5 years' experience working in quality assurance within a pharmaceutical company or CRO focused on clinical trials;
- Strong knowledge of CRO / Healthcare / Pharmaceutical Vendor Management Quality Assurance activities and understanding of vendor oversight strategies in regulated environments;
- Strong background in QA and GxP auditing, especially GCP is essential and experience across other GxP areas (GLP, GPvP, GMP, GDP) is advantageous;
- Critical thinker with a proactive, solutions-focused mindset;
- Ability to travel across the region if required;
- Appropriate tertiary qualifications in the medical, pharmaceutical or healthcare disciplines (MSc or PhD is highly desirable).
We are a growing business within the Asia Pacific region, committed to quality, collaboration, and continuous improvement. We are proud to be certified as a Great Place To Work in Australia.
We Offer- An attractive remuneration and benefits package;
- Genuine work-life balance;
- Flexibility and discussion on what might work for you to meet your work/life commitments and support your wellbeing;
- Career stability and security;
- Much more.
We value inclusivity, diversity, and equality, and commit to creating a safe and inclusive environment that celebrates the diversity of our employees.
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