Global QC Validation Lead – On-Site Startup & Validation

Telix Pharmaceuticals (AMER); United States; On-site; USD 120,000 - 160,000; Full time

Job summary

Telix Pharmaceuticals is seeking a Quality Control Validation Lead to support the startup and readiness of QC laboratories across the Telix Manufacturing Solution network. The role involves extensive travel across US sites to establish compliant QC operations, transfer and validate methods, and ensure regulatory readiness.

You will collaborate with Quality Control, Manufacturing, Technical Operations, and Regulatory groups to maintain inspection readiness and support regulatory submissions while

Qualifications

• Experience with analytical method development, validation, and transfer within GMP environments.
• Regulatory knowledge for FDA/ICH guidelines and 21 CFR 211/212.
• Strong data integrity and documentation practices.

Responsibilities

• Lead QC startup, qualification, validation, and readiness across the network.
• Coordinate calibration, maintenance, qualification, and lifecycle of equipment.
• Develop and maintain GMP-compliant laboratory systems and data integrity.

Skills

Analytical Method Development

Method Transfer & Validation

GMP Regulatory Compliance

Quality Systems & Documentation

Root Cause Analysis

Education

Bachelor’s degree in Chemistry/Pharmaceutical Sciences

Advanced degree (M.S./Ph.D.) preferred

Tools

HPLC/LC-MS

Analytical Instruments

Job description

Telix Pharmaceuticals is seeking a Quality Control Validation Lead to support the startup and readiness of QC laboratories across the Telix Manufacturing Solution network. The role involves extensive travel across US sites to establish compliant QC operations, transfer and validate methods, and ensure regulatory readiness.

You will collaborate with Quality Control, Manufacturing, Technical Operations, and Regulatory groups to maintain inspection readiness and support regulatory submissions while