Global CQV Lead, Travel-Heavy GMP Validation

Telix Pharmaceuticals (AMER); Oregon; Hybrid; USD 130,000 - 180,000; Full time

Benefits offered by this job

Annual performance-based bonuses

Equity-based incentive program

Generous vacation

Support for learning and development

Job summary

Telix Pharmaceuticals is seeking a CQV Lead to provide quality assurance oversight for facility commissioning, qualification and validation across the Telix Manufacturing Solution network in the United States. The role reports to the Quality Director, Manufacturing Expansion & Readiness, and requires travel exceeding 75% with extended site stays as needed.

You will partner with Engineering, Validation, Manufacturing, QC, IT, and Regulatory Affairs to ensure cGMP compliance and readiness for

Qualifications

• Bachelor’s degree in a scientific discipline (Pharmacy, Chemistry, Biochemistry, Engineering, Life Sciences) required
• 5+ years in Quality Assurance, Validation, Engineering Quality, or CQV within pharma/biotech/radiopharma
• Minimum 5 years supporting CQV for GMP facilities and manufacturing systems
• Experience reviewing VMPs, URS, DQ, IQ/OQ/PQ, risk assessments, and validation reports
• Willingness to travel >75% across multiple US sites

Responsibilities

• Review and approve validation lifecycle documentation (VMPs, risk assessments, protocols, reports)
• Ensure facility startup, expansion and remediation meet cGMP and 21 CFR Parts 210-212
• Apply risk-based approaches to commissioning, qualification and validation
• Review deviations, investigations, CAPAs, change controls and risk assessments
• Collaborate with Engineering, Validation, Manufacturing, QC, IT and Regulatory Affairs to ensure GMP readiness
• Monitor milestones, deliverables and site-readiness metrics; elevate risks
• Support technology transfers and site activations; handoff to on-site QA/QC teams
• Lead readiness activities for regulatory inspections and audits

Skills

Quality Assurance

CQV

GMP compliance

Validation

Risk assessment

Documentation

Cross-functional collaboration

English

Education

Bachelor's degree in Pharmacy, Chemistry, Biochemistry, Engineering, Life Sciences

Advanced degree desirable

Job description

Telix Pharmaceuticals is seeking a CQV Lead to provide quality assurance oversight for facility commissioning, qualification and validation across the Telix Manufacturing Solution network in the United States. The role reports to the Quality Director, Manufacturing Expansion & Readiness, and requires travel exceeding 75% with extended site stays as needed.

You will partner with Engineering, Validation, Manufacturing, QC, IT, and Regulatory Affairs to ensure cGMP compliance and readiness for