Senior Director, Internal Manufacturing Quality

Telix Pharmaceuticals (AMER); United States; Remote; USD 180,000 - 240,000; Full time

Benefits offered by this job

Annual performance-based bonus

Equity-based incentive program

Generous vacation

Wellness days

Learning & development support

Job summary

Telix Pharmaceuticals is seeking a Sr Director of Manufacturing Quality to lead global strategy, governance, and performance across regions. You will ensure regulatory compliance, GMP alignment, and inspection readiness for internal sites while collaborating with Manufacturing, Supply Chain, and R&D to deliver high-quality radiopharmaceutical products.

This fully remote role requires ~30% travel, including international travel, and leadership of a global quality organization to drive continuous

Qualifications

• Experience leading global quality programs in pharma/biotech.
• Proven ability to drive quality improvements and inspection readiness.
• Strong knowledge of GMP, regulatory expectations, and ICH guidelines.
• Demonstrated leadership of regional quality teams and cross-functional partners.
• Ability to develop and implement risk-based quality strategies.

Responsibilities

• Define and execute a global manufacturing quality strategy aligned to regulatory requirements.
• Lead regional Quality Directors and BU heads to drive performance and compliance.
• Own escalation and CAPA programs for deviations, OOS, and supply disruptions.
• Drive continuous improvement and quality maturity across sites.
• Partner with Regulatory, Supply Chain, and Manufacturing to ensure inspection readiness.

Skills

Quality leadership

Regulatory compliance

GMP knowledge

ICH Q9/Q10 familiarity

CAPA & risk management

Cross-functional leadership

Tools

Quality systems

Job description

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

TheSr DirectorofManufacturingQualityleads the global strategy, governance, and performance management of theregional quality programs. This role ensures thatinternal sitesmeet regulatory, quality, and business requirements to enable uninterrupted supply of GMP/GDP materials, components, intermediates, and finished products.The Sr Director ofManufacturingQualitywillhelpshape 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.Asakeymemberofourcorporatequalityleadershipteam, thisindividualwillplayacrucialroleinensuringtheongoingcompliance,qualitystandards,andinspectionreadinessofourinternal sites.

This role is fully remote with about 30%travelrequired, including international travel.

Key Accountabilities

• GlobalManufacturingQuality Strategy & Leadership

  • Define and execute a global internal manufacturingquality strategy aligned to company goals and regulatory requirements
  • Establish standardized internalquality 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 manufacturingescalation point for quality issues and determine what issues need to be escalated to Head of Telix Quality.

• RegionalTeamsOversight

  • Lead and develop theRegional Directors (Americas, EMA, APAC) and internal Qualitybusiness unit heads.
  • Oversee processes for tracking, monitoring, and communicating internal manufacturingriskstoQuality, Compliance, and GlobalLeadership.
  • Influencefunctional organizationstorecognizeandaddresssystemicqualityissuestodrivecontinuousimprovements,mitigatingrisk, and support betterinspectionreadiness.
  • 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

  • Driveimprovements in product quality
  • Establish and monitorregional quality metrics and dashboards.
  • Lead cross-regional root causeanalysis 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-relateddisruptions.
  • Serve as a keydecision-makerand escalation point within cross-functional crisis management.
  • Partner with Procurement, Operations, and Technicalteams to resolve quality issues and drive continuous improvement.

• ContinuousImprovement

  • Create a living Quality Transformation plan aroundManufacturingQuality 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

• CollaborationandCommunication

  • Partner with Manufacturing Operations, Supply Chain, Development, Regulatory, and Global Quality teams
  • LeadcrossfunctionalteamsinQualityimprovementinitiatives

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

At Telix, we believe everyone counts , we strive to be extraordinary , and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what’s next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.

Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.

VIEW OUR PRIVACY POLICY HERE