Quality Control Lead — Radiopharma (Hybrid/Remote + Equity)

Telix Pharmaceuticals Limited; San Francisco (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Telix Pharmaceuticals is seeking a Quality Control Lead to coordinate analytical method development, validation, transfer, and routine QC testing for radiopharmaceutical products in a site-based role. You will draft methods, specifications, and reports, review data for cGMP compliance, and oversee equipment qualification and external testing coordination.

As a senior QC expert, you will lead deviations, investigations, CAPAs, and change controls, ensuring regulatory readiness and robust QA

Qualifications

• Bachelor’s degree in radiochemistry, chemistry, pharmacy, biochemistry, or a related scientific discipline required.
• 5+ years’ experience in pharmaceutical or biotechnology Quality Control, analytical development, or GMP lab operations.
• Experience with analytical chemistry techniques, including chromatography and other relevant testing methods.
• Experience with analytical method development, validation, verification, or.
• Experience supporting stability programs, specifications, deviations, OOS/OOT investigations, CAPAs, and laboratory change controls.
• Working knowledge of pharmaceutical Quality Systems and applicable cGMP requirements, including 21 CFR Parts 210 and 211.
• Experience supporting facility or laboratory commissioning, qualification, validation, or operational readiness.
• Experience coordinating work with contract laboratories or external testing providers.
• Radiopharmaceutical, radiochemistry, or radioactive-material handling experience.

Responsibilities

• Coordinate analytical method development, validation, transfer, stability testing, and routine QC testing for clinical and commercial radiopharmaceutical products.
• Draft and maintain analytical methods, specifications, protocols, reports, and QC documentation.
• Review analytical data and laboratory records for accuracy, completeness, and compliance with cGMP.
• Coordinate laboratory equipment qualification, calibration, maintenance, and external testing.
• Review and manage materials, reagents, and reference standards; coordinate external lab testing and review results.
• Lead or support deviations, OOS/OOT investigations, CAPAs, and change controls.
• Ensure QC activities comply with procedures, data-integrity standards, radiation-safety requirements, and applicable regulations.
• Support internal and external audits and regulatory inspections.

Skills

GMP knowledge

Analytical chemistry

Chromatography

Quality systems

Documentation

Education

Bachelor’s degree in radiochemistry or related science

Job description

Telix Pharmaceuticals is seeking a Quality Control Lead to coordinate analytical method development, validation, transfer, and routine QC testing for radiopharmaceutical products in a site-based role. You will draft methods, specifications, and reports, review data for cGMP compliance, and oversee equipment qualification and external testing coordination.

As a senior QC expert, you will lead deviations, investigations, CAPAs, and change controls, ensuring regulatory readiness and robust QA