Senior Quality Assurance Associate

Southern Star Research is a leading Australian, privately owned CRO headquartered in Sydney. 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 the 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.

We are looking for a talented, full-time Senior Quality Assurance Associate to join our team in Australia. In this role, you will work closely with cross-functional teams to ensure the effectiveness of quality processes, facilitate audits, and support training initiatives.

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:

• Assist in the development and ongoing maintenance of the QMS to ensure regulatory compliance.
• Upload QMS documentation and training materials to the Learning Management System (LMS) and assign training to stakeholders.
• Facilitate client audits, prepare materials, and manage follow-up actions.
• Draft responses for client quality questionnaires and surveys.
• Support clinical computerised system qualifications and implementations.
• Coordinate and report on internal and external audits, including TMF reviews.
• Assist in developing the annual audit program and manage regulatory agency inspections.
• Investigate quality issues, implement corrective actions, and track resolution.
• Mentor Quality Assurance Associates and maintain training records.
• Generate quality metric reports for management and assist in preparing QMS performance metrics.
• Respond to stakeholder queries regarding GCP compliance and quality assurance.
• Ensure compliance with privacy breach protocols and maintain up-to-date knowledge of regulatory guidelines.

Does this sound like you?

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

• Minimum of two years experience working in a commercial Clinical Quality Assurance environment, with a minimum of 5 years overall experience working in clinical research.
• Appropriate tertiary qualifications in the medical, pharmaceutical or healthcare disciplines (MSc or PhD is highly desirable).
• Background in leading and participating in audits with a Good Clinical Practice (GCP) focus, in addition to practical working knowledge of drug development.
• Comprehensive working knowledge of state and federal regulations pertaining to GCP and ISO guidelines including the ability to apply the requirements of regulation practically.
• Experience in developing, writing and reviewing standard operating procedures.
• Experience in deviation and Quality Issue management.
• Experience facilitating and conducting audits.
• Veeva Vault eQMS experience preferred.

Why Southern Star Research?

Southern Star Research is a growing business within the Asia Pacific region and this is an ideal opportunity to contribute to maintaining high-quality standards in a dynamic and growing organisation. If you’re passionate about quality assurance and eager to make a difference, we’d love to hear from you! 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;
• Office located in Gordon – under cover parking provided and close to public transport;
• STAR day – one extra day off per year for you to recharge 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.