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 Head of Quality (APAC) provides senior Quality leadership and oversight for Telix’s internal radiopharmaceutical manufacturing network in the Asia-Pacific region, including the Yokohama and North Melbourne production sites. The role ensures product quality, regulatory compliance, inspection readiness, and continuous improvement for both diagnostic and therapeutic radiopharmaceutical products, including PET, SPECT, and radioligand therapy (RLT) manufacturing.

This leader acts as the primary Quality interface across the Americas region, partnering closely with Site Heads, Operations, Supply Chain, Engineering, Regulatory, and Global Quality Systems to maintain consistent Quality standards, drive performance, and uphold a “Safety & Quality Always” culture.

Key Accountabilities

Regional Quality Leadership

Provide strategic and hands-on Quality leadership for all Telix APAC internal sites, with primary oversight of Yokohama (Japan) and Blackwood (Australia).
Act as the regional Quality decision-maker for product release, Quality events, batch disposition, and validation
Ensure alignment with global Quality policies, governance frameworks, and lifecycle management

Compliance & Regulatory Readiness

Ensure full compliance with relevant regulatory frameworks:
Japan (PMDA): GMP/biopharmaceutical standards, aseptic manufacturing expectations, radiopharmaceutical
Australia (TGA): PIC/S GMP, Annex 1, radiation safety and radiopharmaceutical compounding
Maintain readiness for regulatory inspections, internal audits, and customer audits across both
Conduct periodic regional Quality reviews, site assessments, and compliance health

Operational Quality Oversight

Oversee batch record review, batch release, sterility assurance, QC testing, environmental monitoring, and aseptic
Lead decision-making for deviations, OOS/OOT investigations, complaints, and equipment/facility impact
Support facility and equipment expansions, new line installations, automation or digital systems upgrades, and tech transfer activities across APAC sites.

Quality Systems & Performance Management

Monitor and improve KPIs for investigations, CAPA, batch release, EM results, complaints, and supplier
Ensure consistent application of ALCOA++ data integrity principles across all systems and
Partner with Global Quality Systems to deploy system upgrades, digital tools, and process

People Leadership

Provide leadership, coaching, and development for regional Quality
Support hiring, onboarding, and capability building within site Quality
Promote a culture of transparency, accountability, and continuous

Cross-Functional Collaboration

Collaborate with Operations, Engineering, Regulatory Affairs, EHS, Supply Chain, and R&D to ensure Quality alignment and operational execution.
Support APAC regional initiatives such as:
Facility modernization and capacity
New product introductions and lifecycle
Process improvement projects focused on reducing deviations and increasing
Serve as the regional Quality escalation pathway for sterilization, contamination control, environmental monitoring, and radiation safety issues.

Position Requirements

Education and Experience

Bachelor’s degree in a scientific discipline (Chemistry, Pharmacy, Engineering, or related field)
10–15+ years of progressive Quality leadership in pharmaceutical or radiopharmaceutical GMP
7 years of Quality leadership experience in pharmaceutical or radiopharmaceutical GMP