Quality Control, Validation 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.

Responsibilities

• Support QC laboratory startup, qualification, validation, and operational readiness across the 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 manufacturing; support technology transfers for new products, processes, and analytical methods; coordinate internal and contract laboratory activities; develop and maintain stability programs, protocols, and documentation.
• Author and maintain analytical methods, specifications, protocols, reports, and QC documentation; review analytical data, validation results, deviations, OOS/OOT investigations, CAPAs, and change controls; lead root cause analysis for analytical failures, atypical results, and quality issues; maintain readiness for regulatory inspections and internal or customer audits; support analytical content for regulatory submissions and health authority responses.
• Standardize and improve QC practices, analytical procedures, and validation approaches across the TMS network; travel more than 75% to provide on‑site support for startup, qualification, validation, and commercial readiness.

Requirements

• 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 QC laboratories and analytical testing (21 CFR 211, 212).
• Experience in 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, reviewing, and approving analytical