[Hiring] Senior Director, Internal Manufacturing Quality @AMER

Role Description

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
  • 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
  • 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 initiatives effectively through regular business reviews and performance assessments.
• Operational Quality & Performance
  • 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.
• Issue Management & Quality Escalation
  • Lead response and escalation processes for deviations, OOS, critical defects, and supply-related disruptions.
  • Serve as a key decision-maker and escalation point within cross-functional crisis management.
  • Partner with Procurement, Operations, and Technical teams to resolve quality issues and drive continuous improvement.
• Continuous Improvement
  • Create a living Quality Transformation plan around Manufacturing Quality Initiatives with actions.
  • Lead transformation initiative to elevate quality maturity and operational excellence across regions.
  • Scale best practices across sites and regions.
  • Drive implementation of digital tools.
• Collaboration and Communication
  • Partner with Manufacturing Operations, Supply Chain, Development, Regulatory, and Global Quality teams.
  • Lead cross-functional teams in Quality improvement initiatives.

Key Capabilities

• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do.
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results.
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges.
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language.
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals.
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges.
• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected.
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges.
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders.
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills.