Director, Product Development Quality

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Telix Pharmaceuticals Limited

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501 - 1000 Mitarbeiter

Gegründet 2015

🏥 Gesundheitswesen

💼 Beratung

🧬 Biotechnologie

Healthcare • Consulting • Biotechnology

Telix Pharmaceuticals Limited ist ein biopharmazeutisches Unternehmen im kommerziellen Stadium, das sich der Transformation der Diagnose und Behandlung von Krebs und seltenen Krankheiten widmet. Mit einem Fokus auf die Entwicklung und Kommerzialisierung von theranostischen Radiopharmazeutika nutzt Telix zielgerichtete Strahlung, um die Entscheidungsfindung bei der Behandlung zu verbessern und personalisierte Therapien bereitzustellen. Mit einer umfangreichen Pipeline, die Bereiche wie Prostata- und Nierenkrebs, Neuro-Onkologie und muskuloskelettale Krebserkrankungen adressiert, hat Telix globale behördliche Zulassungen für seinen führenden Bildgebungsagenten Illuccix® erhalten und führt weltweit zahlreiche klinische Studien durch.

Beschreibung

• 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

🎯 Anforderungen

• 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.

🏖️ Vorteile

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