Quality Assurance Associate

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 and to improve the quality of life for people living with cancer and rare diseases.

We are seeking a highly motivated and detail‑oriented QA Operations Specialist to support the international roll‑out of our approved prostate cancer imaging agent and advance our portfolio of late‑clinical‑stage products.

• Understand and adhere to GMP policies.
• Prepare, review, and maintain quality documents within the QMS (Master Control), including document control and lifecycle support.
• Support training management, ensuring training matrices and records are accurate and up to date in the QMS.
• Support internal and external audits, supplier quality activities, and CMO oversight, including document reviews, audit participation, and quality agreements.
• Assist functional areas with achieving timely and compliant final product dispositions of the product being manufactured.
• Participate in writing, implementing, and approving deviations, investigations, CAPA, change control, and complaint reports and ensure timely, compliant closure.
• Ensure compliance of site personnel and application of aseptic techniques and full compliance to sterile manufacturing regulations.
• Participate in the management of supplier and vendor assurance activities and supplier quality agreements.
• Lead FDA/Regulatory interactions for the Angleton site activities and products to ensure successful regulatory submissions and inspections.
• Perform QA operations as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance, and data integrity.
• Collaborate with manufacturing, supply chain, and cross‑functional teams, supporting batch review, batch release activities, and continuous improvement of the QMS.

• Bachelor’s degree in Life Sciences, Quality Management, or a related field.
• 3+ years of experience in a quality assurance role.
• Experience in GxP sterile manufacturing operations.
• Cross‑functional collaboration is required.
• Ability to work in a team environment and communicate effectively with diverse groups.
• Willingness to work with radioactive materials and follow strict safety protocols.
• Technical understanding of manufacturing, quality, and regulatory requirements.
• Previous experience writing and reviewing SOPs and specifications.

• Inclusive mindset and commitment to diversity.
• Creativity and innovation.
• Commitment to excellence.
• Results‑oriented focus.
• Ethical behavior and integrity.
• Adaptability and willingness to take on new challenges.
• Strong communication skills.
• Collaboration with colleagues and stakeholders.
• Resilience in the face of setbacks.
• Continuous learning and professional development.

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.