Sterility Assurance ManagerAre 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.What's in it for You?
Lead contamination control strategies in a dedicated GMP manufacturing site with a focus on innovation and continuous improvementInfluence facility expansion, validation, and technology transfers in a sector with high patient impactPlay a critical role during regulatory inspections as a site subject matter expertBe part of a multidisciplinary team supporting both clinical and future commercial productsDevelop your leadership in a pivotal role that directly supports patient safetyKey ResponsibilitiesLead microbiology, contamination control, environmental monitoring, and sterility assurance programsDevelop and maintain contamination control strategies aligned with GMP and industry best practicesOversee environmental monitoring, including trend analysis and program optimisationSupport aseptic process simulations, cleanroom qualifications,



and contamination assessmentsLead investigations into microbiological deviations and support CAPA implementationEnsure compliance with Australian and international regulatory standards during inspections and auditsProvide technical leadership and mentorship across microbiology, quality, and manufacturing teamsWhat We're Looking ForBachelor's degree in Microbiology, Biology, Biochemistry, Biotechnology or related field8+ years in sterile pharmaceutical, biologics, or radiopharmaceutical GMP manufacturing environments3+ years leading contamination control, microbiology, or aseptic processing teamsProven experience managing contamination risk assessments and environmental monitoring programsStrong knowledge of GMP, Australian TGA standards, and international contamination control best practicesExcellent communication and stakeholder management skillsExperience supporting audits, regulatory submissions, and complex investigationsDesirable SkillsAdvanced training or certifications in microbiology, contamination control, or quality systemsExperience in radiopharmaceutical manufacturing or nuclear medicine environmentsKnowledge of EU GMP Annex 1, facility start-up, and process validationFamiliarity with digital environmental monitoring tools and data analytics
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📌 Sterility Assurance Manager (Brisbane)
🏢 Fuse Recruitment
📍 Brisbane