Telix Pharmaceuticals Limited
Biotechnology • Pharmaceuticals • Healthcare Insurance
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.
501 - 1000 employees
Founded 2015
🧬 Biotechnology
💊 Pharmaceuticals
⚕️ Healthcare Insurance
Manager, Clinical Quality
Job not on LinkedIn
October 16
Telix Pharmaceuticals Limited
Biotechnology • Pharmaceuticals • Healthcare Insurance
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.
501 - 1000 employees
Founded 2015
🧬 Biotechnology
💊 Pharmaceuticals
⚕️ Healthcare Insurance
📋 Description
• Establish, implement and maintain quality assurance processes and documented procedures. • Plan, conduct and report audits and assessments of Good Clinical Practices (GCPs) and Good Pharmacovigilance Practices (GVP). • Ensure accurate audit documentation from audits. • Drive inspection preparation activities for regulatory authority inspections. • Provide quality oversight and compliance support for various study teams. • Ensure accurate review and investigation of clinical trial related investigations. • Review processes to identify gaps in standards. • Collaborate with Clinical Operations to write and revise SOPs.
🎯 Requirements
• Bachelor’s degree in Life Sciences or related discipline required; Master’s degree preferred. • American Society for Quality (ASQ) Certification in Quality Auditing, Quality Management, Six Sigma Green Belt or Six Sigma Black Belt required. • 7+ years of experience in Clinical Quality for Manager level and 9+ years in Clinical Quality for Sr. Manager level leading teams in the biotech/pharmaceutical industry • Experience with FDA, TGA, PMDA, ICH and EMEA guidelines and regulations • Excellent time management skills and the ability to work with a sense of urgency • Strong oral and written communication including the ability to present information clearly and logically • Ability to prioritize and manage multiple projects to meet critical deadlines • Strong attention to detail and problem-solving skills • Works effectively in a team environment.
🏖️ Benefits
• Competitive salaries • Annual performance-based bonuses • Equity-based incentive program • Generous vacation • Paid wellness days • Support for learning and development
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