Senior Quality Assurance Manager, CSIRO

CSIRO

Location:
Australia, Melbourne

Category:
Quality Control

Contract Type:
Employment contract

Salary:

157000.00 - 174000.00 AUD / Year

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Job Description:

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. Ensure quality assurance oversight and support project execution within the Regulated Biomanufacturing and Biomedical Materials Translation laboratories.

Job Responsibility:

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
Serve as point of accountability for customers and project teams for quality oversight of manufacturing and quality control operations
Act as trusted advisor to clients and regulators
Lead compliance efforts across CSIRO Regulated Biomanufacturing facilities
Manage documentation systems and analyse QA data
Mentor and supervise QA teams
Build national and international networks and secure new project opportunities

Requirements:

Advanced degree in Microbiology, Biotechnology, Biochemical Engineering or related field or equivalent experience
Minimum 10 years industry experience in GMP quality assurance within pharmaceutical or biopharmaceutical manufacturing
Expert knowledge of TGA regulatory requirements and international harmonised GMP standards
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 and setting up effective teams
Demonstrated experience influencing third parties through communication

Nice to have:

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
Demonstrated proactive approach to risk identification and mitigation
Demonstrated compliance mindset and attention to detail

What we offer:

15.4% superannuation
Flexible work arrangements
Range of leave entitlements
Career development opportunities

Additional Information:

Job Posted:
September 24, 2025

Expiration:
October 26, 2025

Employment Type:

Fulltime

Work Type:

On-site work

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Senior Quality Assurance Manager