Quality Assurance CQV

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. 

See Yourself at Telix

The Quality Assurance Commissioning, Qualification, and Validation (CQV) Lead is a highly mobile, site-based role requiring extensive travel across the Telix Manufacturing Solution (TMS) network in the United States. Reporting to the Quality Director, Manufacturing Expansion & Readiness, the role provides Quality Assurance support and oversight for facility construction and expansion, equipment and utility qualification, computerized systems validation, process validation, and operational readiness.

Travel is expected to exceed 75% and may require extended stays of several weeks at a site, depending on project schedules, validation timelines, and readiness milestones. The role partners with Engineering, Validation, Manufacturing, Quality Control, IT, and Regulatory Affairs to ensure CQV activities meet applicable cGMP requirements and Telix Quality Systems.

The position will support the implementation of quality oversight, validation strategies, risk management practices, documentation, and inspection-readiness activities needed to transition sites from project execution to routine GMP operations and support clinical and commercial manufacturing.

Key Accountabilities:

CQV & Quality Oversight

Provide Quality Assurance oversight for CQV and operational readiness activities across the TMS network.

• Review and approve validation lifecycle documentation, including VMPs, risk assessments, protocols, reports, and qualification
• Ensure facility startup, expansion, and remediation activities comply with applicable cGMP requirements, including 21 CFR Parts 210, 211, and 212, as relevant to the site.
• Apply risk-based approaches to commissioning, qualification, and validation

Quality Systems & Compliance

Support the implementation of quality systems, procedures, and governance needed to transition facilities into routine GMP operations.

• Review and approve deviations, investigations, CAPAs, change controls, and quality risk assessments related to CQV Contribute to consistency and compliance of qualification and validation practices at assigned sites.