Director, Product Development Quality

🕒 Julho 27

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Telix Pharmaceuticals Limited

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

Fundada em 2015

🏥 Saúde

💼 Consultoria

🧬 Biotecnologia

Healthcare • Consulting • Biotechnology

A Telix Pharmaceuticals Limited é uma empresa biofarmacêutica em estágio comercial dedicada a transformar a forma como o câncer e doenças raras são diagnosticados e tratados. Com foco no desenvolvimento e comercialização de radiofármacos teranósticos, a Telix utiliza radiação direcionada para aprimorar a tomada de decisões terapêuticas e oferecer uma terapia personalizada. Com um extenso pipeline que aborda áreas como câncer de próstata e rim, neuro-oncologia e cânceres musculoesqueléticos, a Telix obteve aprovações regulatórias globais para seu principal agente de imagem, o Illuccix®, e está conduzindo ativamente inúmeros ensaios clínicos em todo o mundo.

Descrição

• Lead the Development Quality function, supporting radiopharmaceutical development programs from early clinical development through registration-readiness • 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 • Provide GMP quality oversight for development-stage radiopharmaceutical programs • 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 • Provide Development Quality input and oversight for IND/CTA submissions, clinical-stage GMP activities, and CTD Module 3 quality content • Support the implementation and continuous improvement of Development Quality procedures, templates, and governance practices • Lead and develop Development Quality team members, including coaching, workload management, performance feedback, and capability building

🎯 Requisitos

• Advanced degree (MS, PharmD, PhD) in a relevant scientific discipline strongly preferred; bachelor’s degree with equivalent experience considered • 10+ years of progressive quality experience within the pharmaceutical, biotechnology, or radiopharmaceutical industry, with demonstrated depth in development-stage GMP quality • 7+ years of leading and developing quality teams, including experience building greenfield or newly established quality functions • Direct experience in radiopharmaceutical quality required, including familiarity with short half-life manufacturing, real-time release testing, and USP <821> compliance; oncology or targeted therapy development quality experience preferred • Demonstrated experience with IND/CTA submissions, NDA/BLA quality strategy, and CTD Module 3 authorship or oversight; direct regulatory agency interaction experience (FDA, EMA, and/or PMDA) required • Comprehensive understanding of Good Manufacturing Practices (GMP) and regulatory requirements • Proven ability to work with cross-functional teams and maintain effective relationships with key business partners • Strong communication and educational skills to support GxP and regulatory knowledge across the organization • Experience in documentation practices and record-keeping, ensuring accuracy and compliance.

🏖️ Benefícios

• Competitive salaries • Annual performance-based bonuses • Equity-based incentive program • Generous vacation • Paid wellness days • Support for learning and development