Director of Commercial Product Quality

Director, Commercial Product Quality - Telix Pharmaceuticals Limited

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company dedicated to delivering precision medicine through targeted radiation for cancer and rare diseases. We are seeking a Director, Commercial Product Quality to ensure the highest standards of product quality and compliance in our commercial manufacturing operations.

About the Role

This leadership position is crucial for overseeing quality across intermediates, Bulk Drug/API, Drug Product, Packaging and Labeling, and Commercial Distribution. You will leverage your deep understanding of quality assurance, regulatory compliance, and pharmaceutical manufacturing to enhance our quality management systems, drive continuous improvement, and collaborate with cross-functional teams.

Key Responsibilities

• Good Manufacturing Practices (GMP): Ensure expert understanding and application of ICH and GMP standards from global health authorities, governing radiopharmaceutical and medical device production. Educate business partners on GxP requirements.
• Pharmaceutical Quality Systems in Manufacturing: Maintain formalized systems to ensure manufacturing processes meet quality standards. Lead strategic quality improvements and ensure PQS alignment across sites.
• Quality Assurance and Control: Guarantee products meet quality standards throughout production and prior to release. Collaborate with matrix teams on pipeline products and establish an analytical framework for quality problem-solving, fostering skill development within the team.
• Regulatory Compliance: Demonstrate in-depth knowledge of life sciences regulatory requirements, ensuring departmental alignment with current expectations. Lead company-wide initiatives to improve continuous compliance and develop the overall regulatory compliance strategy.
• Documentation and Record-Keeping: Ensure documentation practices align with authority expectations internally and with contract partners. Collaborate with business partners and suppliers to ensure all required documentation is captured within Telix.

Education and Experience

• Bachelor’s degree in a relevant scientific or engineering field; advanced degree preferred.
• 12+ years of experience in quality within the pharmaceutical or biotechnology industry.
• 8+ years of people leadership experience in the pharmaceutical or biotechnology industry.
• Proven experience in driving continuous improvement of pharmaceutical quality systems in a regulated environment.
• Demonstrated success in driving continuous improvement initiatives and achieving measurable results.

Key Capabilities

• Inclusive mindset
• Adaptability
• Strong communication skills
• Creativity and innovation
• Commitment to excellence
• Results-oriented
• Ethical behavior
• Collaboration
• Resilience
• Continuous learning

Why Telix?

Join an engaged and supportive team with a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Be part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. 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.

Key skills/competency

• Quality Assurance
• Good Manufacturing Practices (GMP)
• Regulatory Compliance
• Pharmaceutical Quality Systems (PQS)
• Radiopharmaceuticals
• Life Sciences Industry
• Quality Control
• ICH Guidelines
• FDA Regulations
• EMA Regulations