Director, Product Development Quality

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases. See Yourself at Telix As the Director, Product Development Quality, you will lead the Development Quality function, supporting radiopharmaceutical development programs from early clinical development through registration-readiness. This role carries direct accountability for leading and scaling a high-performing Development Quality team to support the organization’s strategic transition from PET diagnostics into radiopharmaceutical therapeutics. You will establish and govern QMS elements specific to development-stage programs, represent Quality at the leadership level, and serve as a primary Quality interface with regulatory agencies, CDMOs, and clinical supply partners. The ideal candidate is a seasoned quality leader with deep expertise in radiopharmaceutical GMP, development-stage quality experience, and the ability to lead cross-functional quality execution in a high-growth environment. Key Accountabilities: Good Manufacturing Practices (GMP) Provide GMP quality oversight for development-stage radiopharmaceutical programs, including alignment with applicable ICH, FDA, EMA, PMDA, USP <821>, and relevant 10 CFR requirements governing radioactive drug substances and drug products. Partner with cross-functional teams to apply fit-for-purpose GxP expectations for radiopharmaceutical development programs. Support quality oversight for short half-life manufacturi