Senior Manager, Clinical Quality

🔥 13 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 10%

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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

• Establish, implement and maintain quality assurance processes and documented procedures for compliant clinical trials and reliable clinical data • Plan, arrange, schedule and conduct GCP, GVP and GCLP audits and assessments • Write audit plans, agendas and reports and track audit responses and resulting CAPAs • Drive regulatory authority inspection preparation and coordinate inspection responses • Provide quality oversight and compliance support to study, program, development and matrix teams • Review essential documents and attend relevant team meetings • Review, investigate and close temperature excursions, product complaints and clinical trial-related investigations • Review critical processes and procedures to identify clinical-trial quality gaps • Participate in risk management, data management, trial management and investigational product management initiatives • Collaborate with Clinical Operations to write, revise and approve SOPs, Work Instructions and Forms

🎯 Requirements

• Bachelor’s degree in Life Sciences or related discipline required • American Society for Quality (ASQ) Certification in Quality Auditing, Quality Management, Six Sigma Green Belt or Six Sigma Black Belt required • 7+ 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 ability to work with a sense of urgency • Strong oral and written communication, including 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

🏖️ 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 Telix employees globally