Quality Control Manager

Fuse Recruitment; Brisbane; On-site; AUD 170,000 - 210,000; Full time

Job summary

Fuse Recruitment in Brisbane is seeking an experienced leader to oversee QC laboratory operations for radiopharmaceutical production, driving compliance, modernisation, and team performance in a regulated environment.

You will shape laboratory systems, manage cross-functional regulatory interfaces, and ensure readiness for inspections and audits, with site-based leadership and hands-on oversight.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Microbiology, radiochemistry, or related field.
• 8+ years in regulated GMP environments, with at least 3 years managing laboratory teams.
• Strong GMP, data integrity, and quality systems knowledge in pharma/biotech.
• Experience working in a sterile manufacturing environment.
• Experience with analytical techniques like HPLC, chromatography, spectroscopy.
• Proven track record supporting regulatory audits and inspections.
• MSc or PhD in a relevant discipline.
• Background in radiopharmaceuticals, nuclear medicine, or radioactive materials.
• Experience with LIMS, laboratory automation, or environmental monitoring.
• Knowledge of Australian radiation safety and regulatory frameworks.
• This role involves site-based shift work and hands-on laboratory leadership.

Responsibilities

• Lead day-to-day QC laboratory operations, focusing on testing, sample management, and release procedures.
• Drive staff leadership, training, and continuous development of QC personnel.
• Oversee analytical testing, deviations, investigations, and compliance with GMP and radiation safety standards.
• Implement and continuously improve laboratory systems, including LIMS and automation tools.
• Manage external laboratory relationships and outsourced activities.
• Support strategic projects such as technology transfers and validation initiatives.
• Maintain inspection readiness and facilitate internal and external audits.

Skills

Staff leadership

Regulatory compliance

Stakeholder management

Problem solving

Quality systems

GMP knowledge

Education

Bachelor’s degree in Chemistry/Biochemistry/Pharmaceutical Sciences/Microbiology/Radiochemistry

MSc or PhD in a relevant discipline

Tools

LIMS

Laboratory automation

Job description

Seeking an experienced leader to oversee critical GMP laboratory operations at our Brisbane site. If you excel in driving compliance, continuous improvement, and team performance within a regulated environment, this role offers the scope to make a substantial impact on radiopharmaceutical quality and growth.

What you’ll gain:

• Lead a specialised, technical environment supporting clinical and commercial radiopharmaceutical production
• Directly influence laboratory modernisation and process optimisation initiatives
• Partner closely with manufacturing, quality, and regulatory teams in a collaborative setting
• Play a pivotal role in inspection readiness and regulatory audits for a high-growth sector
• Manage a dedicated team within a high-stakes, site-based environment
• Contribute to innovative projects supporting early and late-stage development

Key responsibilities:

• Lead day-to-day QC laboratory operations, focusing on testing, sample management, and release procedures
• Drive staff leadership, training, and continuous development of QC personnel
• Oversee analytical testing, deviations, investigations, and compliance with GMP and radiation safety standards
• Implement and continuously improve laboratory systems, including LIMS and automation tools
• Manage external laboratory relationships and outsourced activities
• Support strategic projects such as technology transfers and validation initiatives
• Maintain inspection readiness and facilitate internal and external audits

What we’re looking for:

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Microbiology, Radiochemistry, or related field
• 8+ years in regulated GMP environments, with at least 3 years managing laboratory teams
• Strong understanding of GMP, data integrity, and quality systems in pharma or biotech
• Experience working in a sterile manufacturing environment
• Experience with analytical techniques like HPLC, chromatography, spectroscopy
• Proven track record supporting regulatory audits and inspections
• Excellent stakeholder management and problem-solving skills
• MSc or PhD in a relevant discipline
• Background in radiopharmaceuticals, nuclear medicine, or radioactive materials
• Experience with LIMS, laboratory automation, or environmental monitoring
• Knowledge of Australian radiation safety and regulatory frameworks
• This role involves site-based shift work and hands-on laboratory leadership.