Sterility Assurance Manager

Fuse Recruitment; City of Brisbane; On-site; AUD 150,000 - 190,000; Full time

Job summary

Fuse Recruitment is seeking a Sterility Assurance Manager to lead microbiology, contamination control, and sterility assurance within a GMP radiopharmaceutical manufacturing environment. This role offers strategic leadership, hands-on oversight, and interaction with regulatory bodies.

You will drive environmental monitoring, aseptic processing support, and CAPA programs while guiding cross-functional teams across quality and manufacturing. Senior expertise in GMP standards and TGA is essential.

Qualifications

• 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.

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.

Skills

Sterility Assurance

Microbiology

Contamination control

Environmental monitoring

CAPA

GMP compliance

Regulatory inspections

Stakeholder management

Education

Bachelor's degree in Microbiology, Biology, Biochemistry, Biotechnology or related field

Job description

Sterility Assurance Manager

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