Quality Control, Validation Lead

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.

The Quality Control Validation Lead supports the startup and readiness of Quality Control laboratories across the Telix Manufacturing Solution (TMS) network, providing technical and quality oversight for laboratory commissioning, qualification, validation, analytical methods, equipment, systems, and testing processes supporting clinical and commercial manufacturing. The lead partners with site Quality Control, Manufacturing, Technical Operations, Validation, Regulatory, and external laboratories to establish compliant QC operations, transfer and validate methods, qualify equipment, support regulatory submissions, and maintain inspection readiness.

This is a highly mobile, on-site role requiring more than 75% travel across multiple U.S. manufacturing sites, including stays of several weeks at a site. Travel will be driven by site startup, qualification, validation, method transfer, and operational readiness timelines.

• - Support QC laboratory startup, qualification, validation, and operational readiness across TMS
• - Coordinate equipment calibration, maintenance, qualification, and lifecycle
• - Establish GMP-compliant laboratory systems, procedures, documentation, and data integrity
• - Transition validated laboratories to on-site QC

• - Lead analytical method development, transfer, verification, and validation for clinical and commercial
• - Support technology transfers for new products, processes, and analytical
• - Coordinate internal and contract laboratory
• - Develop and maintain stability programs, protocols, and

• - Author and maintain analytical methods, specifications, protocols, reports, and QC
• - Review analytical data, validation results, deviations, OOS/OOT investigations, CAPAs, and change
• - Lead root cause analysis for analytical failures, atypical results, and quality
• - Maintain readiness for regulatory inspections and internal or customer
• - Support analytical content for regulatory submissions and health authority responses, as

• - Standardize and improve QC practices, analytical procedures, and validation approaches across the TMS

Travel more than 75% to provide on-site support for startup, qualification, validation, and commercial readiness.

• - Bachelor's degree required in Chemistry, Biochemistry, Pharmaceutical Sciences, Analytical Chemistry, Microbiology, Radiochemistry, or related scientific discipline. Advanced degree preferred.
• - Strong knowledge of FDA, ICH, USP, and applicable regulatory requirements governing Quality Control laboratories and analytical testing 21FR 211, 212.
• - Development, Validation, or GMP laboratory operations within the pharmaceutical, biotechnology or radiopharmaceutical industry.
• - Demonstrated experience in analytical method development, method validation, method transfer, and analytical lifecycle
• - Experience supporting laboratory investigations, OOS/OOT events, deviations, CAPAs, change controls, and regulatory inspections within a GMP environment.
• - Experience authoring,…