Head of Quality, APAC

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 Blackwood 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-FunctionalCollaboration

• 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
• Strong experience in aseptic production, radiopharmaceutical manufacturing (PET/SPECT or radioligand therapy), QC testing, and batch release.
• Experience supporting or leading multiple manufacturing sites
• Successful track record managing PMDA, TGA, or PIC/S

Technical Competencies

• Expertise in:
  • GMP for radiopharmaceuticals (PMDA, TGA, PIC/S, USP <823>, USP <825>).
  • Aseptic operations, contamination control, radiation safety, and isotopes
  • Deviation/CAPA management, Quality risk management (ICH Q9), validation (ICH Q7/Q8/Q10).
• Familiarity with electronic QMS systems (MasterControl or equivalent), LIMS, and digital Quality

Leadership Competencies

• Strategic thinker with strong operational problem-solving
• Excellent communicator with the ability to influence across functions and
• Demonstrated ability to lead during ambiguity, growth, and organizational
• Strong commitment to patient safety, compliance, and quality

Travel Requirements

• 25–35% travel across the Americas region (primarily US-based sites).

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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