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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 The Senior Manager, Development Quality serves as a senior technical and operational quality leader within the Development Quality function, providing expert oversight of CDMO/CMO quality activities and driving continuous improvement across development-stage radiopharmaceutical programs. This role leads the execution of quality management system processes — including deviation management, CAPA, change control, and batch record review — and functions as a primary quality interface with external manufacturing partners. The Senior Manager brings deep radiopharmaceutical GMP expertise, exercises independent judgment on complex quality issues, and provides guidance and mentorship to junior quality team members. As the organization transitions from PET diagnostics into radiopharmaceutical therapeutics, this role plays a key part in building scalable quality processes and supporting IND-stage program needs across multiple country jurisdictions. Key Accountabilities: Good Manufacturing Practices Lead GMP compliance oversight for radiopharmaceutical development programs manufactured by CDMOs/CMOs, including real-time GMP monitoring, batch disposition support, and proactive identification of compliance risks specific to short half-life manufacturing environments. Quality Management Systems in Manufacturing Own the preparation, review, and approval of key QMS documents within Telix PQS, and lead cross-functional process improvements to enhance the effectiveness and efficiency of the development-stage quality system. Provide senior-level guidance to manufacturing, project, and CMC teams on PQS requirements and quality expectations; serve as a subject matter expert on QMS processes for development-stage radiopharmaceutical Quality Assurance and Control Lead and independently execute batch release activities for investigational radiopharmaceutical products, including review and approval of batch records, QC results, and certificate of analysis documentation from CDMOs/CMOs. Provide senior review and approval of SOPs, batch records, QC results, and regulatory documents; independently assess compliance gaps and escalate risk-based recommendations to the Director, Development Regulatory Compliance Demonstrate expert-level knowledge of radiopharmaceutical GMP requirements including PIC/S GMP, ICH guidelines, 21 CFR 210, 211, and 212, and USP <821>; provide interpretive guidance to teams and support regulatory submission quality inputs (IND/CTA Module 3). Documentation and Record-Keeping Lead the authoring, review, and approval of deviations, investigations, CAPAs, and change controls; mentor junior team members on investigation methodology, root cause analysis, and CAPA effectiveness evaluation to build team capability. People Leadership and Vendor Management Provide day-to-day guidance, mentorship, and technical oversight to junior Development Quality team members; contribute to onboarding, training development, and performance support within the Lead quality oversight of CDMO/CMO relationships, including conducting or co-leading supplier audits, managing audit observations through closure, and escalating systemic quality risks to the Director, Development Quality. Represent Development Qual