Senior Quality Assurance Manager
Senior Quality Assurance Manager
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Acknowledgement of Country
CSIRO acknowledges the Traditional Owners of the land sea and waters of the area that we live and work on across Australia. We acknowledge their continuing connection to their culture and pay our respects to their Elders past and present.View our vision towards reconciliation
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 Australias premier scientific organisation!
About CSIRO
As Australias 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.
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 industrys 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 CSIROs 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:101261
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 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. Dont 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 theTalent Consultantas mentioned on the position description and let us know how we can support you.
Life at CSIRO and flexible work arrangements
Wework flexibly at CSIRO offering a range of options for how when and where you can discuss flexible work arrangements with you during the recruitment also offers a range of leave entitlementsbenefitsandcareer developmentopportunities. To find out more visitCareers at CSIRO.
Inclusion and belonging
Solving Australias 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 creatingdiverse and inclusive teamswhere 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 ourChild 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 asonedocument.
Applications close
26 October 2025 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.
Required Experience:
Manager
Employment Type
Full-Time
