Quality Assurance, CQV Lead
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Job Description
Quality Assurance CQV Lead overseeing validation and GMP readiness for Telix’s radiopharmaceutical manufacturing network. Supporting facility expansion, site activation, audits, and operational handoffs across U.S. sites.
Responsibilities:
- Provide Quality Assurance oversight for commissioning, qualification, validation, and operational readiness activities across the Telix Manufacturing Solution network
- Review and approve validation lifecycle documentation, including VMPs, risk assessments, protocols, reports, and qualification documentation
- Ensure facility startup, expansion, and remediation activities comply with applicable cGMP requirements
- Apply risk-based approaches to commissioning, qualification, and validation
- Support implementation of quality systems, procedures, and governance for transition to routine GMP operations
- Review and approve deviations, investigations, CAPAs, change controls, and quality risk assessments related to CQV
- Promote data integrity, quality culture, and GMP compliance
- Partner with Engineering, Validation, Manufacturing, Quality Control, IT, and Regulatory Affairs
- Monitor project milestones, validation deliverables, and site-readiness metrics; escalate compliance risks
- Support technology transfers, manufacturing readiness, site activation, and handoff to on-site Quality Assurance and Quality Control teams
- Lead readiness activities for regulatory inspections and internal or customer audits
- Coordinate and monitor contractors, validation consultants, engineering firms, and service providers supporting CQV activities
- Support facility construction and expansion, equipment and utility qualification, computerized systems validation, process validation, and operational readiness
- Report to the Quality Director, Manufacturing Expansion & Readiness
- Travel extensively across the U.S. Telix Manufacturing Solution network, with travel expected to exceed 75% and possible multi-week site stays
Requirements:
- Bachelor’s degree required, oriented in Pharmacy, Chemistry, Biochemistry, Engineering, Microbiology, Life Sciences, or a related scientific discipline
- 5 years of experience in Quality Assurance, Validation, Engineering Quality, or CQV within the pharmaceutical, biotechnology or radiopharmaceutical industry
- Minimum 5 years of direct experience supporting Commissioning, Qualification, and Validation (CQV) activities for GMP facilities and manufacturing systems
- Experience reviewing and approving Validation Master Plans (VMPs), User Requirement Specifications (URS), Design Qualification (DQ), IQ/OQ/PQ protocols, risk assessments, and validation reports
- Technical understanding of manufacturing, quality and regulatory requirements
- Experience writing and reviewing SOPs
- Willingness and ability to travel more than 75% across multiple U.S. manufacturing sites, including extended stays of several weeks
- English language
- Knowledge of applicable cGMP requirements, including 21 CFR Parts 210, 211, and 212
- Ability to work with validation documentation, quality systems, risk management, deviations, investigations, CAPAs, and change controls
Benefits:
- Competitive salaries
- Annual performance-based bonuses
- Equity-based incentive program
- Generous vacation
- Paid wellness days
- Support for learning and development
- Hybrid and remote work arrangements are available across the company
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