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 Assurance Associate Director (Hinseki) is responsible for establishing, maintaining, and improving the Pharmaceutical Quality System (PQS) to support the Marketing Authorization Holder (MAH) operations in Japan. As the designated Quality Assurance Responsible Person and a member of the MAH management triad, the role partners with the Soseki (General Manufacturing and Marketing Responsible Person) and Anseki (Safety Management Responsible Person) to ensure compliance with Japanese GQP, GVP, PMDA, and other applicable regulatory requirements.
The position provides quality leadership for MAH licensing, regulatory inspections, product release, quality risk management, post-marketing quality activities, and continuous inspection readiness.
The role operates under a dual reporting structure:
- Functional Reporting: Senior Director, Internal Manufacturing Quality, for corporate quality strategy and performance management.
This functional reporting line does not override or limit the Hinseki's statutory responsibilities under the Japanese GQP Ordinance, independent quality judgement, authority to make quality decisions, or obligation to report quality or compliance matters to the Soseki.
- Regulatory Reporting: Soseki, for statutory GQP responsibilities, quality decisions, product quality issues, recalls, and regulatory compliance required of the Hinseki.
The QA Associate Director (Hinseki) has the authority to make independent quality decisions and escalate quality or compliance issues to the Soseki and Quality leadership to ensure patient safety, product quality, and regulatory compliance.
Key Accountabilities:
Quality Management System
- Establish, implement, and maintain the Japan GQP-compliant Pharmaceutical Quality System.
- Develop, review, approve, and maintain GQP Standard Operating Procedures (SOPs), quality agreements, and related quality documentation.
- Ensure effective document control, training, change control, deviation management, CAPA management, complaint handling, and quality risk management processes.
- Support continuous improvement initiatives to maintain an inspection-ready state.
MAH Licensing and Regulatory Compliance
- Support compliance with Japan MAH requirements, including the responsibilities of the Soseki, Hinseki, and Anseki functions in accordance with the Pharmaceuticals and Medical Devices Act (PMD Act) and expectations of the Tokyo Metropolitan Government.
- Work collaboratively with the Anseki (Safety Management Responsible Person) to ensure alignment between quality and safety management activities, including product complaints, recalls, quality defects, and regulatory reporting requirements.
Inspection Readiness and Audits
- Lead and coordinate MAH inspection readiness activities.
- Prepare the organization for PMDA, Tokyo Metropolitan Government, and partner audits and inspections.
- Host regulatory inspections and quality audits as required.
- Manage inspection observations, audit findings, and associated CAPA activities.
Quality Oversight and Supplier Management
- Provide quality oversight of contract manufacturers, testing laboratories, distributors, and service providers.
- Support qualification, monitoring, and auditing of GxP service providers.
- Review and approve Quality Technical Agreements and Supplier Quality Agreements.
Product Quality and Compliance
- Review and evaluate deviations, investigations, complaints, change controls, and CAPAs for products supplied to the Japanese market.
- Ensure product quality issues are appropriately assessed, documented, escalated, and resolved.
- Support product release and disposition activities as required under the MAH quality system.
Cross-Functional Leadership
- Serve as the primary quality representative for Japan MAH activities.
- Provide quality guidance and training to internal stakeholders regarding GQP and regulatory requirements.
- Collaborate with global and local teams to ensure alignment of quality and regulatory objectives.
- Support NDA applications, collaborate with Regulatory Affairs to address PMDA and regulatory authority questions related to quality system, manufacturing and product quality.
Position Requirements
Education and Experience:
- Bachelor's degree in a science-related field + 7 years experience, or Masters +5 years experience
- Minimum 7 years' experience in pharmaceutical Quality Assurance within Japan, with qualifications and experience meeting the requirements for appointment as a Quality Assurance Responsible Person (Hinseki) under the Japanese GQP Ordinance.
- Strong knowledge of Japanese pharmaceutical regulations, including GQP, GMP, GVP, and MAH requirements.
- Sound understanding of PMDA expectations and inspection practices.
- Knowledge of Tokyo Metropolitan Government requirements for MAH establishment and maintenance.
- Excellent technical writing and SOP development skills.
- Strong leadership, communication, and stakeholder management capabilities.
- Ability to work effectively in a bilingual Japanese-English environment.
- Strong risk management, problem-solving, and decision-making skills.
- Experience with Quality Management Systems (QMS).
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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