Director, Commercial Product Quality

About the role

Telix Pharmaceuticals is seeking a Director, Commercial Product Quality to lead quality and compliance for its commercial manufacturing operations worldwide. The role oversees intermediates, bulk drug, drug product, packaging, labeling and distribution, ensuring the highest standards for radiopharmaceuticals and related medical devices.

Key responsibilities

• Provide expert guidance on GMP, ICH and GxP standards across all commercial sites.
• Maintain and improve Pharmaceutical Quality Systems (PQS) and ensure alignment across locations.
• Lead the Quality Assurance and Control function to guarantee product quality during production and release.
• Develop and execute regulatory compliance strategies and continuous‑improvement initiatives.
• Oversee documentation and record‑keeping practices to meet authority expectations.
• Collaborate with cross‑functional and third‑party teams on pipeline products and early‑stage quality requirements.
• Educate business partners on fit‑for‑purpose quality requirements and foster analytical problem‑solving capabilities.

Required profile

• Extensive experience in quality assurance, regulatory compliance and GMP within the pharmaceutical or biotechnology industry.
• Proven leadership of quality functions in commercial manufacturing environments.
• Strong understanding of radiopharmaceutical production and medical device regulations.
• Track record of driving strategic quality improvements and cross‑functional collaboration.

Required skills

• Good Manufacturing Practices (GMP)
• ICH guidelines
• GxP compliance
• Pharmaceutical Quality Systems (PQS)
• Regulatory compliance strategy
• Documentation and record‑keeping
• Analytical problem‑solving