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Telix Pharmaceuticals is seeking a Senior Manager, Commercial Product Quality to lead quality efforts in compliance with GMP standards for their radiopharmaceutical products. This fully remote role focuses on ensuring quality excellence throughout product lifecycles while working collaboratively with various internal and external teams.
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Job Summary
The role provides strategic and operational quality leadership across Chemistry, Manufacturing, and Controls (CMC) activities to ensure compliance with global Good Manufacturing Practice requirements.
This position supports the international roll-out of approved prostate cancer imaging agents and advances late clinical-stage products addressing unmet needs in oncology and rare diseases.
The successful candidate will drive continuous improvement initiatives, oversee contract manufacturing organizations, and collaborate with cross-functional teams on key product projects moving through commercialization.
Matching Summary
Match Score: 75
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Telix Pharmaceuticals is seeking a Senior Manager, Commercial Product Quality to lead quality efforts in compliance with GMP standards for their radiopharmaceutical products. This fully remote role focuses on ensuring quality excellence throughout product lifecycles while working collaboratively with various internal and external teams.
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Skills & Requirements
Must-have
8+ years pharmaceutical quality experience
GMP compliance with FDA EMA ICH guidelines
Experience with CMO/CDMO oversight
Batch disposition and deviation management
Risk assessment and CAPA processes
Nice-to-have
Radiopharmaceutical industry background
Cross-functional collaboration skills
Continuous improvement initiatives
Data analysis and trending programs
Mentoring QA professionals
Key Requirements
Bachelor's degree in Pharmaceutical Sciences or Life Sciences
8+ years experience in Quality within pharma/biotech
Strong understanding of Risk Management and Regulatory frameworks