Global CQV QA Lead - GMP Validation & Site Readiness

Telix Pharmaceuticals Limited; United States; On-site; USD 130,000 - 190,000; Full time

Benefits offered by this job

Competitive salaries

Bonuses

Equity program

Generous vacation

Wellness days

Learning & development support

Job summary

Telix Pharmaceuticals Limited is seeking a CQV Lead to provide QA oversight for commissioning, qualification and validation across the Telix Manufacturing Solution network in the United States. The role requires extensive travel and collaboration with Engineering, Validation, Manufacturing, QA, IT and Regulatory Affairs to ensure GMP readiness.

Reporting to the Quality Director, Manufacturing Expansion & Readiness, you will review validation lifecycle documentation and ensure compliance with

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Biochemistry, Engineering, Microbiology, Life Sciences or related field.
• Minimum 5 years in Quality Assurance, Validation, Engineering Quality or CQV in pharma/biotech/radiopharma.
• Experience reviewing Validation Master Plans, URS, DQ, IQ/OQ/PQ, risk assessments and validation reports.

Responsibilities

• Provide QA oversight for CQV and readiness across the Telix Manufacturing Solution network.
• Review and approve validation lifecycle docs (VMPs, risk assessments, protocols, reports).
• Ensure startup, expansion and remediation activities comply with cGMP and 21 CFR Parts 210, 211, 212.
• Support quality systems, governance, deviations, CAPAs, change controls and risk assessments.
• Collaborate with Engineering, Validation, Manufacturing, QA, IT and Regulatory Affairs; monitor milestones and site readiness.

Skills

English

Travel willingness

Quality systems knowledge

Regulatory awareness

Education

Bachelor’s degree in Pharmacy or related science

Job description

Telix Pharmaceuticals Limited is seeking a CQV Lead to provide QA oversight for commissioning, qualification and validation across the Telix Manufacturing Solution network in the United States. The role requires extensive travel and collaboration with Engineering, Validation, Manufacturing, QA, IT and Regulatory Affairs to ensure GMP readiness.

Reporting to the Quality Director, Manufacturing Expansion & Readiness, you will review validation lifecycle documentation and ensure compliance with