Quality Assurance, CQV Lead

🔥 15 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Telix Pharmaceuticals Limited

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2015

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Telix Pharmaceuticals Limited is a commercial-stage biopharmaceutical company dedicated to transforming the way cancer and rare diseases are diagnosed and treated. Focusing on the development and commercialization of theranostic radiopharmaceuticals, Telix utilizes targeted radiation to enhance treatment decision-making and deliver personalized therapy. With an extensive pipeline addressing areas such as prostate and kidney cancer, neuro-oncology, and musculoskeletal cancers, Telix has garnered global regulatory approvals for its lead imaging agent, Illuccix®, and is actively conducting numerous clinical trials worldwide.

📋 Description

• 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