Job Description

Sterility Assurance Manager

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Are you ready to lead microbiology, contamination control, and sterility assurance in a high-growth radiopharmaceutical workplace? 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.

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What's in it for You?

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- Lead contamination control strategies in a dedicated GMP manufacturing site with a focus on innovation and continuous improvement
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- Influence facility expansion, validation, and technology transfers in a sector with high patient impact
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- Play a critical role during regulatory inspections as a site subject matter expert
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- Be part of a multidisciplinary team supporting both clinical and future commercial products
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- Develop your leadership in a pivotal role that directly supports patient safety
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Key Responsibilities

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- Lead microbiology, contamination control, environmental monitoring, and sterility assurance programs
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- Develop and maintain contamination control strategies aligned with GMP and industry best practices
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- Oversee environmental monitoring, including trend analysis and program optimisation
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- Support aseptic process simulations, cleanroom qualifications, and contamination assessments
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- Lead investigations into microbiological deviations and support CAPA implementation
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- Ensure compliance with Australian and international regulatory standards during inspections and audits
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- Provide technical leadership and mentorship across microbiology, quality, and manufacturing teams
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What We're Looking For

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- Bachelor's degree in Microbiology, Biology, Biochemistry, Biotechnology or related field
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- 8+ years in sterile pharmaceutical, biologics, or radiopharmaceutical GMP manufacturing environments
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- 3+ years leading contamination control, microbiology, or aseptic processing teams
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- Proven experience managing contamination risk assessments and environmental monitoring programs
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- Strong knowledge of GMP, Australian TGA standards, and international contamination control best practices
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- Excellent communication and stakeholder management skills
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- Experience supporting audits, regulatory submissions, and complex investigations
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Desirable Skills

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- Advanced training or certifications in microbiology, contamination control, or quality systems
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- Experience in radiopharmaceutical manufacturing or nuclear medicine environments
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- Knowledge of EU GMP Annex 1, facility start-up, and process validation
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- Familiarity with digital environmental monitoring tools and data analytics
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📌 Sterility Assurance Manager (Queensland)
🏢 Fuse Recruitment
📍 Queensland