QA Operations Lead

About the role

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. We are seeking a highly motivated and detail-oriented QA Operations Lead to join our radiopharmaceutical quality team.

Responsibilities

• Understand and adhere to GMP Policies
• Provide manufacturing quality oversight of all production, quality control, and supply chain departments to monitor all work according to requirements under ITG quality system.
• Review and evaluate all standard operating procedures, batch records and quality control results to ensure compliance with ITG quality and regulatory requirements.
• Perform live review of manufacturing batch records in preparation for batch release and escalate any exceptions immediately as requested by the quality system of the site.
• 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.
• Ensure compliance of site personnel and application of aseptic techniques and full compliance to sterile manufacturing regulations.
• Participate in the management of supplier, 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.
• Lead QA Operations as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance and data integrity.
• Provide support to cross-functional team and assist other departments with exception management for compliance and timely closure of exceptions.

Requirements

• Bachelor’s degree in Life Sciences, Quality Management, or related field
• 5+ years of experience in quality assurance role
• Experience in GxP manufacturing operations is requested