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.