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 strong 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 solid 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.

📌 Site Head of Quality (Inala)
🏢 Fuse Recruitment
📍 Inala