Senior QA Manager, Commercial Product Quality - Remote

Overview

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.

In Short

• Ensure the highest standards of product quality and compliance within commercial operations.
• Oversee and enhance quality management systems.
• Drive continuous improvement initiatives.
• Collaborate with cross-functional teams on key product projects.
• Monitor performance metrics and establish trending programs.
• Educate business partners on GxP requirements.
• Maintain relationships with manufacturing partners to ensure compliance.
• Practice meticulous documentation and record-keeping.
• Mentor and guide QA professionals.
• Facilitate decision-making aligned with health authority requirements.

Requirements

• Bachelor’s degree in a relevant scientific or engineering field required; advanced degree preferred.
• 8+ years of experience in quality within the pharmaceutical or biotechnology industry.
• Knowledge of statistical techniques and methodologies for quality assurance.
• Proven experience in developing and managing quality management systems.
• Strong understanding of global regulatory requirements, including FDA and EMA regulations.
• Excellent leadership and communication skills.
• Experience in risk management and CAPA processes.

Benefits

• Competitive salaries.
• Annual performance-based bonuses.
• Equity-based incentive program.
• Generous vacation and paid wellness days.
• Support for learning and development.