Quality Manager, Commercial 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

• Provide leadership and oversight for compliance requirements including training, metrics, recalls, and complaints.
• Monitor and update Pharmaceutical Quality Systems (PQS) in manufacturing.
• Oversee Quality Assurance Agreements (QAAs) with partners.
• Manage changes with third-party vendors.
• Coordinate cross-functional improvement initiatives.
• Lead special quality improvement projects across the organization.
• Ensure compliance with industry standards and regulatory requirements.
• Drive a culture of continuous improvement.
• Prepare reports for senior leadership on project outcomes.
• Analyze data to identify areas for improvement.

Requirements

• Bachelor’s degree in Life Sciences, Biotechnology, Chemistry, Biology, or related field required.
• 7+ years of experience in a quality assurance role in the Pharmaceutical industry.
• Knowledge of regulatory requirements within the life sciences industry.
• Strong understanding of GMP guidelines.
• Familiarity with FDA regulations and guidelines.
• Six Sigma Experience preferred.

Benefits

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