Site Head of Quality – Radiopharmaceutical Manufacturing Join a fast-paced, high-impact environment where your leadership will shape the future of radiopharmaceutical production.
This is a senior leadership role reporting to the Global Head of Quality and sitting on the Site Leadership Team, with a robust mandate to build capability and embed a high-performing quality culture as the site progresses toward commercialisation.
This environment is fast-paced and high-stakes (just-in-time product decisions), so we're looking for a leader who can make sound GMP decisions quickly, lead calmly under pressure, and partner effectively across Operations, Technical, Engineering, Supply Chain, Regulatory and Corporate Quality.
Key responsibilities • Lead the site Quality strategy, priorities, quality roadmap and performance metrics • Own and continuously improve the Quality Management System (QMS) (deviations, CAPA, change control, investigations, complaints, risk management, supplier quality, training, document control, management review) • Provide quality oversight of manufacture, testing, batch review and disposition, and release activities • Lead and support QC laboratory operations (testing programs, environmental monitoring, stability, method validation/maintenance) • Drive validation/qualification oversight (processes, equipment, facilities, utilities, computerised systems, analytical methods) • Maintain inspection readiness and lead/host regulatory inspections and audits (TGA/FDA/EMA/PIC/S/ICH aligned) • Build and develop the Quality team (resourcing, mentoring, capability uplift, succession planning, budget management) • Partner with HSE on radiation safety and compliance requirements relevant to radiopharma manufacturing and distribution What you'll bring (essential)



• Bachelor's degree in a relevant science/engineering discipline (Pharmacy, Chemistry, Microbiology, Biochemistry, Life Sciences, Engineering, etc.) • 12+ years in regulated pharma/biotech/sterile manufacturing (radiopharma/biologics experience highly regarded) • 7+ years leading QA/QC or site quality functions • Strong working knowledge of GMP and global quality standards (TGA, FDA, EMA, PIC/S, ICH) • Proven experience with deviations/CAPA/change control/investigations/batch disposition and maintaining an effective QMS • Confident, decisive leadership style with strong stakeholder influence and communication skills Desirable experience • Radiopharmaceuticals / nuclear medicine / radiochemistry, or radioactive materials management • Clinical-stage to commercial scale-up / commercialisation readiness • Radiation safety frameworks (incl. Australian context such as ARPANSA and transport requirements) • E-systems exposure (eQMS, electronic batch records, LIMS, ERP) and data integrity • Quality/OpEx credentials (Lean Six Sigma, Quality certification, etc.) What's on offer • Senior site leadership appointment in a growing, mission-driven organisation • Significant scope to shape the site Quality function (teams evolving across QA Ops, QA Systems, QC, Sterility Assurance and Validation Is this role right for you?
This is a hands-on, site-based leadership role requiring agility, quick decision-making, and a passion for quality in complex manufacturing.
If you thrive under pressure, have radiopharmaceutical experience or relevant regulated manufacturing expertise, and are ready to influence a fast-growing site, we want to hear from you.
Consultant Amy Heffernan ************ ****** Reference number: BH-***** Profession:Healthcare MedicalPharmaceuticals Medical Devices Company: Fuse Recruitment Date posted: 7th Aug, ****

📌 Site Head Of Quality New (Brisbane)
🏢 Fuse Recruitment
📍 Brisbane