Senior Director, Internal Manufacturing Quality
Telix Pharmaceuticals (AMER)Remote · Posted 3 days agoDescription
Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.
See Yourself at Telix
The Sr Director of Manufacturing Quality leads the global strategy, governance, and performance management of the regional quality programs. This role ensures that internal sites meet regulatory, quality, and business requirements to enable uninterrupted supply of GMP/GDP materials, components, intermediates, and finished products. The Sr Director of Manufacturing Quality will help shape and drive the quality strategy, strengthen quality systems and regulatory compliance, and partner closely with manufacturing, supply chain, R&D, and leadership to deliver consistent, high-quality performance across sites. As a key member of our corporate quality leadership team, this individual will play a crucial role in ensuring the ongoing compliance, quality standards, and inspection readiness of our internal sites.
This role is fully remote with about 30% travel required, including international travel.
Key Accountabilities:
- Global Manufacturing Quality Strategy & Leadership
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- Define and execute a global internal manufacturing quality strategy aligned to company goals and regulatory requirements
- Establish standardized internal quality frameworks, policies, and KPIs across regions for internal manufacturing
- Drive alignment and consistency in quality practices globally while allowing for local regulatory nuance
- Serve as the global internal manufacturing escalation point for quality issues and determine what issues need to be escalated to Head of Telix Quality.
- Regional Teams Oversight
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- Lead and develop the Regional Directors (Americas, EMA, APAC) and internal Quality business unit heads.
- Oversee processes for tracking, monitoring, and communicating internal manufacturing risks to Quality, Compliance, and Global Leadership.
- Influence functional organizations to recognize and address systemic quality issues to drive continuous improvements, mitigating risk, and support better inspection readiness.
- Ensure risk-based qualification aligned with ICH Q9, ICH Q10, and applicable GMP requirements.
- Ensure teams are meeting performance targets and executing global quality initiative effectively through regular business reviews and performance assessments.
- Operational Quality & Performance
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- Drive improvements in product quality
- Establish and monitor regional quality metrics and dashboards.
- Lead cross-regional root cause analysis and CAPA programs
- Build and develop a high-performing global quality organization
- Ensure strong succession planning for regional and site-level quality leaders
- Foster a culture of accountability, transparency, and continuous improvement
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