Director, Product Development Quality

Telix Pharmaceuticals Limited; United States; Hybrid; USD 180,000 - 240,000; Full time

Job summary

Telix Pharmaceuticals Limited is seeking a Director of Development Quality to lead the Development Quality function, ensuring GMP compliance for radiopharmaceutical programs from early development through registration-readiness. You will govern QMS elements and partner with regulatory, CDMOs, and clinical supply to deliver quality across development stages.

The ideal candidate has 10+ years in pharmaceutical/biotech quality with deep radiopharmaceutical expertise, and 7+ years leading quality

Qualifications

• Advanced degree (MS, PharmD, PhD) in a relevant scientific discipline strongly preferred; bachelor's degree with equivalent experience considered.
• 10+ years of progressive quality experience in pharmaceutical/biotech/radiopharmaceutical industry with development-stage GMP quality.
• 7+ years of leading and developing quality teams, including building greenfield or newly established quality functions.
• Direct experience in radiopharmaceutical quality including short half-life manufacturing, real-time release testing, and USP compliance.
• Experience with IND/CTA submissions, NDA/BLA quality strategy, and CTD Module 3 authorship/oversight; regulatory agency interaction (FDA/EMA/PMDA) required.
• Understanding of GMP and regulatory requirements; ability to work cross-functionally and communicate effectively.

Responsibilities

• Provide development quality input for IND/CTA submissions and CTD Module 3 quality content.
• Oversee clinical-stage GMP activities and CDMO oversight for development programs.
• Ensure quality systems are documented, scalable, and aligned with enterprise standards.
• Lead and develop the Development Quality team, including coaching and performance feedback.
• Partner with Regulatory Affairs, CMC, Clinical Operations, Manufacturing, and external partners to manage quality risks.
• Support regulatory interactions, inspections, and submission-related activities for development programs.

Skills

Cross-functional leadership

Quality governance

Regulatory liaison

GMP knowledge

Strategic thinking

Communication

Team development

Education

MS/PhD in a relevant scientific discipline

Bachelor's degree with equivalent experience

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 As the Director, Product Development Quality, you will lead the Development Quality function, supporting radiopharmaceutical development programs from early clinical development through registration-readiness. This role carries direct accountability for leading and scaling a high-performing Development Quality team to support the organization’s strategic transition from PET diagnostics into radiopharmaceutical therapeutics. You will establish and govern QMS elements specific to development-stage programs, represent Quality at the leadership level, and serve as a primary Quality interface with regulatory agencies, CDMOs, and clinical supply partners. The ideal candidate is a seasoned quality leader with deep expertise in radiopharmaceutical GMP, development-stage quality experience, and the ability to lead cross-functional quality execution in a high-growth environment.

Key Accountabilities

• Good Manufacturing Practices (GMP): Provide GMP quality oversight for development-stage radiopharmaceutical programs, including alignment with applicable ICH, FDA, EMA, PMDA, USP, and relevant 10 CFR requirements governing radioactive drug substances and drug products.
• Partner with cross-functional teams to apply fit-for-purpose GxP expectations for radiopharmaceutical development programs.
• Support quality oversight for short half-life manufacturing considerations specific to radiopharmaceuticals, including real-time release testing (RTRT), compressed batch release timelines, and in-process control strategies.
• Coordinate with technical teams and the Radiation Safety Officer, as appropriate, on quality interfaces related to hot-cell qualification, dose calibrator validation, and radiation safety program requirements.
• Development Quality and Clinical Supply Oversight
  • Provide Development Quality input and oversight for IND/CTA submissions, clinical-stage GMP activities, and CTD Module 3 quality content.
  • Support quality activities related to clinical investigational medicinal product supply, including CDMO oversight, comparator sourcing, clinical packaging, labeling, distribution, and release requirements.
  • Review and provide quality input on development program documentation, including manufacturing records, specifications, validation documentation, deviations, CAPAs, and change controls.
• Quality Systems and Process Improvement
  • Support the implementation and continuous improvement of Development Quality procedures, templates, and governance practices.
  • Ensure development-stage quality processes are appropriately documented, scalable, and aligned with enterprise Quality standards.
• Partner with Quality leadership to identify gaps, assess risks, and recommend pragmatic solutions for development-stage programs, Cross-Functional Leadership and External Partner Oversight
  • Represent Development Quality in program team meetings, stage-gate discussions, and cross-functional governance forums.
  • Partner with Regulatory Affairs, CMC, Clinical Operations, Manufacturing, Supply Chain, and external partners to ensure quality risks are identified, escalated, and managed.
  • Provide quality oversight of contracted manufacturing, testing, packaging, and clinical supply partners supporting development programs.
• Regulatory Compliance & Inspection Readiness
  • Support regulatory agency interactions, inspections, and submission-related activities as the Development Quality representative.
  • Provide input on development quality risk assessments when regulatory or GMP requirements cannot be fully integrated.
• Support inspection readiness activities for development-stage programs and external partners. People Leadership
  • Lead and develop Development Quality team members, including coaching, workload management, performance feedback, and capability building.
  • Support headcount planning and organizational capability development as the Development Quality function matures.
  • Promote consistent quality decision-making, documentation practices, and cross-functional collaboration.

Education And Experience

• Advanced degree (MS, PharmD, PhD) in a relevant scientific discipline (Pharmacy, Chemistry, Radiochemistry, or related field) strongly preferred; bachelor's degree with equivalent experience considered.
• 10+ years of progressive quality experience within the pharmaceutical, biotechnology, or radiopharmaceutical industry, with demonstrated depth in development-stage GMP quality.
• 7+ years of leading and developing quality teams, including experience building greenfield or newly established quality functions.
• Direct experience in radiopharmaceutical quality required, including familiarity with short half-life manufacturing, real-time release testing, and USP compliance; oncology or targeted therapy development quality experience preferred.
• Demonstrated experience with IND/CTA submissions, NDA/BLA quality strategy, and CTD Module 3 authorship or oversight; direct regulatory agency interaction experience (FDA, EMA, and/or PMDA) required.
• Comprehensive understanding of Good Manufacturing Practices (GMP) and regulatory requirements.
• Proven ability to work with cross-functional teams and maintain effective relationships with key business partners.
• Strong communication and educational skills to support GxP and regulatory knowledge across the organization.
• Experience in documentation practices and record-keeping, ensuring accuracy and compliance.

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.

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