"Senior Quality and Compliance Officer"

Senior Quality and Compliance Officer

Job no: 538299
Work type: Full Time
Location: Sydney, NSW
Categories: Research Infrastructure, Clinical/Medical Research

Senior Quality and Compliance Officer-The Kirby Institute

• Employment Type: Part time/Full-time (21-35 hours a week)
• Duration: 12 Months Fixed Term contract
• Remuneration: $113,926 base, plus 17% superannuation and leave loading
• Work rights required: Visa sponsorship is not available for this position. Candidates must hold full rights to work in Australia to be considered for this position.
• Location: Kensington, Sydney

About The Kirby Institute:

The Kirby Institute is a world-leading health research institute at UNSW Sydney. We work to eliminate infectious diseases, globally. Our specialisation is in developing health solutions for the most at-risk communities. Putting communities at the heart of our research, we develop tests, treatments, cures and prevention strategies that have the greatest chance of success.

Details of the role

The BRIDGE program is a consortium of not-for-profit organisations led by the Kirby Institute, designing and conducting specific clinical development programs (Immunovirology and Pathogenesis Program) for RNA therapeutics that are at least TRL3 and which have an unmet clinical need with potentially viable markets in the area of immunology or infectious diseases.

BRIDGE will conduct studies that support the development of a dossier for submission to the appropriate regulatory such as the TGA or the FDA. The Senior Quality and Compliance Officer will ensure BRIDGE-supported projects align with regulatory expectations for clinical development, providing quality oversight, due diligence, and compliance support across preclinical activities, contractors, and external facilities.

Working closely with the Senior Project Manager – BRIDGE, the role will ensure experimental design, data integrity, documentation, quality systems meet regulatory standards to enable credible transition from research to clinical development.

The role of Senior Quality and Compliance Officer reports to Senior Project Manager - BRIDGE and has no direct reports.

Some key skills required:

• Tertiary qualification in biomedical science, life sciences, pharmacology, biotechnology, or a related discipline
• Demonstrated experience in quality, compliance, or regulatory readiness within preclinical, translational, or early clinical drug development environments
• Working knowledge of regulatory expectations relevant to preclinical and early clinical development, including principles of Good Laboratory Practice, Good Clinical Practice, Good Manufacturing Practice, and data integrity
• Experience reviewing or overseeing animal studies, nonclinical development programs, or translational research activities
• Familiarity with SOP requirements, quality systems, and documentation practices within drug development or contract research settings
• Experience working with external contractors, Clinical Research Organisations, academic laboratories, or animal facilities, including review of study plans and deliverables
• Ability to assess data quality, traceability, and completeness for suitability in regulatory submissions or due diligence reviews
• Strong organisational and documentation skills, with high attention to detail

Please refer to the position description for full details.

UNSW Benefits and Culture

• 17% Superannuation and leave loading
• Flexible working
• Additional 3 days of leave over the Christmas Period
• Access to lifelong learning and career development
• Progressive HR practices

More information on the great staff benefits and culture can be found here.

Pre-Employment Checks:

Aligned with UNSW’s focus on cultivating a workplace defined by safety, ethical conduct, and strong integrity preferred candidates will be required to participate in a combination of pre-employment checks relevant to the role they have applied for.

These pre-employment checks may include a combination of some of the following checks:

• National and International Criminal history checks
• Entitlement to work and ID checks
• Working With Children Checks
• Completion of a Gender-Based Violence Prevention Declaration
• Verification of relevant qualifications
• Verification of relevant professional membership
• Employment history and reference checks
• Financial responsibility assessments/checks
• Medical Checks and Assessments

Compliance with the necessary combination of these checks is a condition of employment at UNSW.

How to apply:

Please click on Apply now to apply online. Applications should not be sent to the contact listed below. Please provide a resume and a separate document addressing the skills and experience listed in the Position Description. A copy of the Position Description can be found on JOBS@UNSW.

Contact

Frank McHenry, Talent Acquisition Associate
E: f.mchenry@unsw.edu.au

Applications close: Sunday 22nd March before 11.30pm Sydney time

UNSW is committed to equity diversity and inclusion. Applications from women, people of culturally and linguistically diverse backgrounds, those living with disabilities, members of the LGBTIQ+ community; and people of Aboriginal and Torres Strait Islander descent, are encouraged. UNSW provides workplace adjustments for people with disability, and access to flexible work options for eligible staff. The University reserves the right not to proceed with any appointment.

Position Description