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 Quality Manager is responsible for managing the production, quality, compliance, and operational efficiency of the Telix facility in Japan. This role ensures adherence to Japanese regulatory requirements (PMDA, MHLW, JNMT), as well as international standards (GMP, IAEA, FDA, EMA). The Quality Manager will oversee production teams, ensure radiation safety, and drive continuous improvement in processes and performance.

Key Accountabilities:
Good Manufacturing Practices (GMP)

• Ensure products meet the highest standards of quality and regulatory compliance.
• Maintain and improve Quality Management Systems (QMS), conduct internal and external audits and support regulatory inspections.

Pharmaceutical Quality Systems in Manufacturing

• Responsible for updating and managing key manufacturing-associated documents in PQS.
• Review and approve deviations, change controls and Corrective and Preventative Actions (CAPAs)

Regulatory Compliance & Safety

• Ensure compliance with Japanese PMDA (Pharmaceuticals and Medical Devices Agency) and MHLW (Ministry of Health, Labour and Welfare) regulations.
• Maintain and enforce radiation safety standards in accordance with Japanese Nuclear Regulation Authority (NRA) guidelines.
• Lead audits and inspections from regulatory bodies, implementing corrective actions as needed.

Quality Assurance & Control

• Oversee Quality Control (QC) and Quality Assurance (QA) processes, ensuring all products meet safety and efficacy standards.
• Maintain accurate documentation, including batch records, SOPs, and deviation reports, in compliance with Japanese and international GMP.
• Collaborate with regulatory and quality teams to investigate and resolve non-conformities.

Leadership & Team Management

• Supervise and mentor Japanese and international staff, fostering a culture of safety, quality, and operational excellence.
• Conduct training programs on radiation safety, GMP, and operational best practices.
• Ensure effective cross-functional collaboration with R&D, regulatory, and commercial teams.

Stakeholder & Business Management

• Support business expansion strategies, including technology upgrades, new product introductions, and site improvements.
• Manage budgets, cost control measures, and resource allocation to meet operational and financial targets.

Education and Experience:

• Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Nuclear Medicine, Engineering, or a related field.
• 5+ years of experience in radiopharmaceutical production, nuclear pharmacy, or GMP manufacturing.
• In-depth knowledge of PMDA, MHLW, and GMP regulations in Japan.
• Experience managing regulatory audits and compliance with radiation safety protocols.
• Strong leadership and team management skills, preferably in a Japanese business environment.
• Fluency in Japanese (N2 level or above preferred) and English.

Preferred Skills & Certifications:

• Certification in Radiation Safety or Nuclear Pharmacy (e.g., RSO training, JNMT certification).
• Experience with Lean Manufacturing, Six Sigma, or Kaizen methodologies.
• Familiarity with automated radiopharmaceutical production systems and software.

Key Capabilities:

• Strong communication skills, effective across all levels of the organization.
• Extensive experience in cGMP, particularly with the PMDA and MHLW in Japan and ideally, experience working with international regulatory authorities.
• Proficient understanding of both early and late-stage drug development processes, including clinical and non-clinical requirements, at an advanced level.
• Strong ability to collaborate effectively with teams across the region.
• Demonstrate a dedication to continuous learning and professional growth, actively pursuing opportunities to enhance your expertise and skill set.
• Uphold integrity and exhibit a steadfast commitment to ethical conduct in all dealings with colleagues and stakeholders.

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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