Senior Quality Assurance Manager

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Role highlight

Lead and implement QA systems for vaccine, protein, and biomedical material manufacturing, ensuring compliance with GMP and TGA standards.

Provide strategic and hands-on technical leadership in regulated biomanufacturing and quality control operations for early-phase clinical projects

Join CSIRO and support Australia\'s premier scientific organisation!

About CSIRO

As Australia\'s national science agency, CSIRO is solving the greatest challenges through innovative science and technology. Many of our iconic innovations were once considered impossible until someone, just like you, joined us and took on the challenge.

Visit CSIRO.au for more information.

At CSIRO, we accelerate sustainable, globally competitive manufacturing for Australia through leading-edge, commercially viable and scalable solutions. The Manufacturing Research Unit is the industry's innovation partner, working together to transform and build sovereign capability by developing new processes, materials and products.

Visit Manufacturing - CSIRO for more information.

The opportunity

We are seeking an experienced Senior Quality Assurance Manager reporting to the Group Leader for Regulated Biomanufacturing to provide both hands-on and strategic technical leadership in quality assurance aspects of manufacturing and quality control operations of vaccines, recombinant proteins and biomedical materials translation.

You will lead and implement quality assurance systems for vaccine, protein, and biomedical material manufacturing and apply advanced scientific expertise to develop and implement quality systems that meet GMP and TGA standards for early-phase clinical manufacturing. You will also ensure quality assurance oversight and support project execution within the Regulated Biomanufacturing and Biomedical Materials Translation laboratories.

This multifaceted role will require working in partnership with Business Development, Research and Development, and Program Leadership to identify and secure new project opportunities and develop opportunities by scoping and authoring comprehensive multidisciplinary project proposals to meet client needs.

Your high-level duties will include :

Provide scientific leadership in quality assurance and control for GMP-regulated manufacturing of therapeutics and biomedical materials.

Set and manage project goals aligned with research priorities, ensuring delivery of outcomes and readiness for regulatory inspections.

Serve as the point of accountability for customers and project teams for quality oversight of manufacturing and quality control operations, including batch record review, deviation management, quality control testing and change control, ensuring readiness for regulatory inspections.

Act as a trusted advisor to clients and regulators, overseeing QA systems, batch records, deviation management, and technology transfer.

Lead compliance efforts across CSIRO Regulated Biomanufacturing (CRB) facilities, guiding regulatory engagement and continuous improvement initiatives.

Manage documentation systems, analyse QA data, and develop performance matrices to strengthen compliance culture and operational efficiency.

Mentor and supervise QA teams, fostering professional growth, collaboration, and alignment with CSIRO\'s values and safety standards.

Build national and international networks, anticipate industry trends, and secure new project opportunities through strategic partnerships and proposal development.

Role particulars

Location :

Clayton, Melbourne, VIC

Salary :

AU$157k - AU$174k per annum (pro-rata for part-time) plus 15.4% superannuation

Tenure :

Full-time; indefinite

Reference :

As a successful candidate, you will bring

Essential

An advanced degree in Microbiology, Biotechnology, Biochemical Engineering or related field or equivalent experience.

Comprehensive industry experience (minimum 10 years) in GMP quality assurance within pharmaceutical or biopharmaceutical manufacturing, preferably in clinical trial material production.

Expert knowledge of TGA regulatory requirements and international harmonised GMP standards (e.g., PIC / S, ICH etc).

Proven experience in leading regulatory inspections and implementing quality systems in a start-up or transitioning facility.

Demonstrated experience in leading staff in large projects, including setting up effective and efficient teams.

Demonstrated experience influencing third parties through communication to gain support for potentially contentious proposals.

Desirable

Direct experience and working knowledge of current GMP frameworks for the manufacture of human vaccines and biotherapeutics with global regulators such as the US Food and Drug Administration, and / or European Medicines Authority.

Demonstrated ability to represent the organisation in external scientific or technological forums and examples of establishing and leading such forums or panel discussions.

Demonstrated proactive approach to risk identification and mitigation.

Demonstrated compliance mindset and attention to detail.

CSIRO thrives on innovation. Innovation that is harnessed by the diversity of the minds and lived experiences brought to our greatest challenges. If you meet some, but not all, requirements, we will still encourage you to submit your application. Feel free to also let us know on your cover letter if you tick a few additional boxes of the desired criteria.

To see the full list of selection criteria for this role, please view the Position Details

Eligibility

Applications for this position are open to Australian Citizens and Australian Permanent Residents only. Appointment to this role is subject to the provision of a national police check and may be subject to other security / medical / character requirements.

Not sure if you meet all the criteria?

While it is CSIRO policy that the successful candidate must meet all the essential criteria, there are many ways to demonstrate this. Don't let the list discourage you. If you are unsure about applying, please reach out to the contact person in the Position Description.

Setting You Up for Success

We are committed to providing a recruitment process that is fair, equitable and accessible to everyone. We recognise that it may be helpful for us to adjust our process to make it equitable for your individual situation. Please contact the Talent Consultant as mentioned on the position description and let us know how we can support you.

Life at CSIRO and flexible work arrangements

We work flexibly at CSIRO, offering a range of options for how, when and where you work. We can discuss flexible work arrangements with you during the recruitment process. CSIRO also offers a range of leave entitlements, benefits and career development opportunities. To find out more, visit Careers at CSIRO.

Inclusion and belonging

Solving Australia\'s greatest challenges takes a diversity of minds and lived experiences. We know diverse teams are more effective and deliver more innovative outcomes. As an equal employment opportunity organisation, we are committed to creating diverse and inclusive teams where people feel they belong. We recognise that true diversity encompasses all ages, abilities, cultures, faiths, levels of education, genders, sexualities, diversity of thought and much more. We focus on hiring people who share our values of People First, Further Together, Making it Real and Trusted.

CSIRO holds Gold Status for the Australian Workplace Equality Index for LGBTQIA+ inclusion, and a Science in Australia Gender Equity Bronze Award.

Child safety

CSIRO is committed to the safety and well-being of all children and young people involved in our activities and programs. View our Child Safe Policy.

How to apply

Please apply online and provide a CV and a detailed cover letter (maximum 2 pages), responding to each of the selection criteria in detail, that best demonstrate your motivation and ability to meet the requirements of this role. Please attach your selection criteria responses to your cover letter as one document.

Applications close

26 October

• , 11 : 00pm AEDT

We strongly encourage you to apply early, as we will review applications as they come in. CSIRO reserves the right to withdraw this ad prior to the closing date, if required.

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