Sterility Assurance Manager
Are you ready to lead microbiology, contamination control, and sterility assurance in a high-growth radiopharmaceutical setting?
This is a strategic, hands-on leadership role supporting the manufacturing of sterileproducts, offering exposure to complex GMP operations and regulatory interactions.
Perfect for an experienced microbiology or contamination control expert seeking impactful scope and autonomy.
What's in it for You?
Lead contamination control strategies in a dedicated GMP manufacturing site with a focus on innovation and continuous improvement
Influence facility expansion, validation, and technology transfers in a sector with high patient impact
Play a critical role during regulatory inspections as a site subject matter expert
Be part of a multidisciplinary team supporting both clinical and future commercial products
Develop your leadership in a pivotal role that directly supports patient safety
Key Responsibilities
Lead microbiology, contamination control, environmental monitoring, and sterility assurance programs
Develop and maintain contamination control strategies aligned with GMP and industry best practices
Oversee environmental monitoring, including trend analysis and program optimisation
Support aseptic process simulations, cleanroom qualifications, and contamination assessments




Lead investigations into microbiological deviations and support CAPA implementation
Ensure compliance with Australian and international regulatory standards during inspections and audits
Provide technical leadership and mentorship across microbiology, quality, and manufacturing teams
What We're Looking For
Bachelor's degree in Microbiology, Biology, Biochemistry, Biotechnology or related field
8+ years in sterile pharmaceutical, biologics, or radiopharmaceutical GMP manufacturing environments
3+ years leading contamination control, microbiology, or aseptic processing teams
Proven experience managing contamination risk assessments and environmental monitoring programs
Strong knowledge of GMP, Australian TGA standards, and international contamination control best practices
Excellent communication and stakeholder management skills
Experience supporting audits, regulatory submissions, and complex investigations
Desirable Skills
Advanced training or certifications in microbiology, contamination control, or quality systems
Experience in radiopharmaceutical manufacturing or nuclear medicine environments
Knowledge of EU GMP Annex 1, facility start-up, and process validation
Familiarity with digital environmental monitoring tools and data analytics
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📌 Sterility Assurance Manager (Brisbane)
🏢 Fuse Recruitment
📍 Brisbane