Director, Product Development Quality
Telix Pharmaceuticals Limited
August 18, 2026
Remote friendly (United States)
United States
Operations
Director, Product Development Quality
Responsibilities
- Provide GMP quality oversight for development-stage radiopharmaceutical programs, aligned with ICH, FDA, EMA, PMDA, USP, and relevant 10 CFR requirements.
- Partner with cross-functional teams to apply fit-for-purpose GxP expectations.
- Oversee short half-life manufacturing quality topics (e.g., RTRT, compressed release timelines, in-process controls).
- Coordinate with technical teams and the Radiation Safety Officer on hot-cell qualification, dose calibrator validation, and radiation safety quality interfaces.
- Provide Development Quality input/oversight for IND/CTA submissions, clinical-stage GMP activities, and CTD Module 3 quality content.
- Support investigational medicinal product supply quality activities (CDMO oversight, comparator sourcing, packaging/labeling, distribution, and release).
- Review development documentation (manufacturing records, specifications, validation, deviations, CAPAs, change controls).
- Implement/continuously improve Development Quality procedures, templates, and governance; ensure scalability and alignment with enterprise Quality.
- Represent Development Quality in stage-gates and governance forums; manage quality risk escalation with internal/external partners.
- Support regulatory interactions/inspections as the Development Quality representative; prepare for inspection readiness.
- Lead and develop the Development Quality team (coaching, workload/performance, capability building).
Qualifications
- Advanced degree (MS, PharmD, PhD) in pharmacy/chemistry/radiochemistry or related field preferred; bachelor’s with equivalent experience considered.
- 10+ years progressive pharmaceutical/biotech/radiopharmaceutical quality experience with development-stage GMP depth.
- 7+ years leading/developing quality teams; experience building new quality functions.
- Required: radiopharmaceutical quality experience (short half-life manufacturing, RTRT, USP compliance); oncology/targeted therapy preferred.
- Direct experience with IND/CTA; NDA/BLA quality strategy; CTD Module 3 authorship/oversight; regulatory agency interaction with FDA/EMA/PMDA required.
Key capabilities
- Results-oriented, strong communication/collaboration, resilience, inclusive mindset, adaptability, ethical behavior, continuous learning.
Responsibilities
- Provide GMP quality oversight for development-stage radiopharmaceutical programs, aligned with ICH, FDA, EMA, PMDA, USP, and relevant 10 CFR requirements.
- Partner with cross-functional teams to apply fit-for-purpose GxP expectations.
- Oversee short half-life manufacturing quality topics (e.g., RTRT, compressed release timelines, in-process controls).
- Coordinate with technical teams and the Radiation Safety Officer on hot-cell qualification, dose calibrator validation, and radiation safety quality interfaces.
- Provide Development Quality input/oversight for IND/CTA submissions, clinical-stage GMP activities, and CTD Module 3 quality content.
- Support investigational medicinal product supply quality activities (CDMO oversight, comparator sourcing, packaging/labeling, distribution, and release).
- Review development documentation (manufacturing records, specifications, validation, deviations, CAPAs, change controls).
- Implement/continuously improve Development Quality procedures, templates, and governance; ensure scalability and alignment with enterprise Quality.
- Represent Development Quality in stage-gates and governance forums; manage quality risk escalation with internal/external partners.
- Support regulatory interactions/inspections as the Development Quality representative; prepare for inspection readiness.
- Lead and develop the Development Quality team (coaching, workload/performance, capability building).
Qualifications
- Advanced degree (MS, PharmD, PhD) in pharmacy/chemistry/radiochemistry or related field preferred; bachelor’s with equivalent experience considered.
- 10+ years progressive pharmaceutical/biotech/radiopharmaceutical quality experience with development-stage GMP depth.
- 7+ years leading/developing quality teams; experience building new quality functions.
- Required: radiopharmaceutical quality experience (short half-life manufacturing, RTRT, USP compliance); oncology/targeted therapy preferred.
- Direct experience with IND/CTA; NDA/BLA quality strategy; CTD Module 3 authorship/oversight; regulatory agency interaction with FDA/EMA/PMDA required.
Key capabilities
- Results-oriented, strong communication/collaboration, resilience, inclusive mindset, adaptability, ethical behavior, continuous learning.