Senior Director, Internal Manufacturing Quality

🕒 il y a 29 jours

🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

🟠 Senior

👔 Directeur

👻 Score fantôme 10%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Telix Pharmaceuticals Limited

Site WebLinkedInTous les Emplois

501 - 1000 employés

Fondée en 2015

🏥 Santé

💼 Conseil

🧬 Biotechnologie

Healthcare • Consulting • Biotechnology

Telix Pharmaceuticals Limited est une entreprise biopharmaceutique en phase commerciale dédiée à transformer la manière dont les cancers et les maladies rares sont diagnostiqués et traités. En se concentrant sur le développement et la commercialisation de radiopharmaceutiques théranostiques, Telix utilise la radiation ciblée pour améliorer la prise de décisions thérapeutiques et fournir des thérapies personnalisées. Avec un vaste portefeuille dans des domaines tels que le cancer de la prostate et du rein, la neuro-oncologie et les cancers musculo-squelettiques, Telix a obtenu des approbations réglementaires mondiales pour son principal agent d'imagerie, Illuccix®, et mène activement de nombreux essais cliniques à travers le monde.

Description

• Lead the global strategy, governance, and performance management of regional manufacturing quality programs • Ensure internal sites meet regulatory, quality, and business requirements for uninterrupted supply of GMP/GDP materials, components, intermediates, and finished products • Shape and drive quality strategy, strengthen quality systems and regulatory compliance, and partner with manufacturing, supply chain, R&D, and leadership • Define and execute a global internal manufacturing quality strategy aligned with company goals and regulatory requirements • Establish standardized internal quality frameworks, policies, and KPIs across regions • Drive global consistency in quality practices while allowing for local regulatory nuance • Serve as the global internal manufacturing escalation point for quality issues • Lead and develop Regional Directors for the Americas, EMA, and APAC and internal quality business unit heads • Oversee tracking, monitoring, and communication of internal manufacturing risks • Influence functional organizations to address systemic quality issues, mitigate risk, and improve inspection readiness • Ensure risk-based qualification aligned with ICH Q9, ICH Q10, and applicable GMP requirements • Conduct regular business reviews and performance assessments • Drive product-quality improvements and monitor regional quality metrics and dashboards • Lead cross-regional root cause analysis and CAPA programs • Build a high-performing global quality organization and succession planning for regional and site-level quality leaders • Lead response and escalation processes for deviations, OOS, critical defects, and supply-related disruptions • Serve as a key decision-maker in cross-functional crisis management • Partner with Procurement, Operations, Technical, Manufacturing Operations, Supply Chain, Development, Regulatory, and Global Quality teams • Create and lead a Quality Transformation plan and manufacturing quality initiatives • Scale best practices across sites and regions and implement digital tools • Lead cross-functional teams in quality improvement initiatives

🎯 Exigences

• Commitment to excellence • Results-oriented approach with focus on measurable results • Creativity and innovation • Strong communication skills • Collaboration skills • Resilience • Inclusive mindset • Adaptability in a dynamic environment • Ethical behavior and integrity • Commitment to continuous learning and professional development • Knowledge of regulatory, quality, and business requirements for GMP/GDP materials, components, intermediates, and finished products • Understanding of ICH Q9, ICH Q10, and applicable GMP requirements

🏖️ Avantages

• Competitive salaries • Annual performance-based bonuses • Equity-based incentive program • Generous vacation • Paid wellness days • Support for learning and development • Fully remote work arrangement • Approximately 30% travel, including international travel