Director, Product Development Quality

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 manufacturing considerations specific to radiopharmaceuticals, including real-time release testing (RTRT), compressed batch release timelines, and in-process control strategies.
  • Coordinate with technical teams and the Radiation Safety Officer, as appropriate, on quality interfaces related to hot-cell qualification, dose calibrator validation, and radiation safety program requirements.
• Development Quality and Clinical Supply Oversight
  • Provide Development Quality input and oversight for IND/CTA submissions, clinical-stage GMP activities, and CTD Module 3 quality content.
  • Support quality activities related to clinical investigational medicinal product supply, including CDMO oversight, comparator sourcing, clinical packaging, labeling, distribution, and release requirements.
  • Review and provide quality input on development program documentation, including manufacturing records, specifications, validation documentation, deviations, CAPAs, and change controls.
• Quality Systems and Process Improvement
  • Support the implementation and continuous improvement of Development Quality procedures, templates, and governance practices.
  • Ensure development-stage quality processes are appropriately documented, scalable, and aligned with enterprise Quality standards.
• Partner with Quality leadership to identify gaps, assess risks, and recommend pragmatic solutions for development-stage programs, Cross-Functional Leadership and External Partner Oversight
  • Represent Development Quality in program team meetings, stage-gate discussions, and cross-functional governance forums.
  • Partner with Regulatory Affairs, CMC, Clinical Operations, Manufacturing, Supply Chain, and external partners to ensure quality risks are identified, escalated, and managed.
  • Provide quality oversight of contracted manufacturing, testing, packaging, and clinical supply partners supporting development programs.
• Regulatory Compliance & Inspection Readiness
  • Support regulatory agency interactions, inspections, and submission-related activities as the Development Quality representative.
  • Provide input on development quality risk assessments when regulatory or GMP requirements cannot be fully integrated.
• Support inspection readiness activities for development-stage programs and external partners. People Leadership
  • Lead and develop Development Quality team members, including coaching, workload management, performance feedback, and capability building.
  • Support headcount planning and organizational capability development as the Development Quality function matures.
  • Promote consistent quality decision-making