Senior Director, Internal Manufacturing Quality

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 10%

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Telix Pharmaceuticals Limited

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2015

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Telix Pharmaceuticals Limited is a commercial-stage biopharmaceutical company dedicated to transforming the way cancer and rare diseases are diagnosed and treated. Focusing on the development and commercialization of theranostic radiopharmaceuticals, Telix utilizes targeted radiation to enhance treatment decision-making and deliver personalized therapy. With an extensive pipeline addressing areas such as prostate and kidney cancer, neuro-oncology, and musculoskeletal cancers, Telix has garnered global regulatory approvals for its lead imaging agent, Illuccix®, and is actively conducting numerous clinical trials worldwide.

📋 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

🎯 Requirements

• 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

🏖️ Benefits

• 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