Senior Quality Assurance Associate

Southern Star Research is a leading Australian, full service CRO headquartered in Sydney, Australia. We specialise in providing clinical research services to a range of clients across the pharmaceutical, medical device and biotechnology markets in Australia, New Zealand and Asia Pacific Region.

We recognise that attracting and retaining excellent staff is the key to developing a high quality CRO and providing our Customers with the best service possible. We greatly value the contributions our staff make to our clients’ projects and to the Company. Southern Star Research’s culture is focused on fostering and maintaining a positive, professional and productive work environment.

Due to continued growth and a strong project pipeline, we’re looking for a talented full-time Quality Assurance Auditor to join our team remotely in either the Philippines or Malaysia. You’ll take the lead on our QA Vendor Qualification activities, providing expert oversight on the assessment and management of new and existing vendors. You’ll collaborate with cross-functional subject matter experts and serve as the go-to expert during client audits and regulatory inspections.

If you’re interested in joining an innovative, exciting, Australian owned CRO, we’d love to talk to you.

About The Role

Reporting to the Head of Quality Assurance, you’ll be responsible for:

• Lead and manage daily vendor qualification operations within the SSR QA team;
• Oversee vendor selection, assessments, and qualifications—including coordination with external auditors;
• 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;
• Conduct vendor scoping and GxP risk assessments; manage new vendor requests;
• 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; and
• Perform any additional responsibilities as assigned.

Beyond vendor qualification, you’ll also contribute to broader QA activities, including:

• Delivering compliance advice
• Conducting internal and external audits
• Supporting sponsor audits and inspections
• Reviewing and improving QA processes; and
• Perform any additional responsibilities as assigned.

Does this sound like you?

To be successful in the role, we’re looking for candidates with:

• Minimum 5 years’ experience working in quality assurance within a pharmaceutical company or CRO focused on clinical trials. CRO experience is preferred;
• Strong knowledge of CRO / Healthcare / Pharmaceutical Vendor Management Quality Assurance activities and understanding of vendor oversight strategies in regulated environments is essential;
• 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; and
• Appropriate tertiary qualifications in the medical, pharmaceutical or healthcare disciplines (MSc or PhD is highly desirable).

Why Southern Star Research?

Southern Star Research is a growing business within the Asia Pacific region and this is an ideal opportunity for someone who is looking to contribute towards our expansion into the APAC region and join a passionate team that’s committed to quality, collaboration, and continuous improvement. Southern Star Research are also proud to be certified as a Great Place To Work in Australia!

We Offer

• An attractive remuneration and benefits package;
• Genuine work-life balance (we appreciate you have hobbies, family and a personal life outside work);
• We value flexibility, and we welcome a discussion on what might work for you to meet your work/life commitments and support your wellbeing;
• Career stability and security and more!

We’d love to connect with you!

Don’t have the all the requirements of this role, but still interested? Please still apply!

Inclusivity, Diversity and Equality

Our commitment is to create a safe and inclusive environment that celebrates the diversity of our employees with their diverse perspectives, backgrounds and cultures.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

Please note that only successful candidates will be contacted.