Senior Manager, Commercial Product Quality – TLX250-CDx, TLX101-CDx

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Telix Pharmaceuticals Limited

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

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.

📋 Description

• Plays a pivotal role in ensuring the highest standards of product quality and compliance within our commercial operations • Responsible for overseeing and enhancing quality management systems • Driving continuous improvement initiatives • Overseeing contract manufacturing organizations • Collaborating with cross-functional teams focusing on TLX250-CDx and TLX101-CDx (18F-FET) moving through the commercialization space

🎯 Requirements

• Bachelor’s degree in a relevant scientific or engineering field required; advanced degree preferred • 8+ years of experience in quality within the pharmaceutical or biotechnology industry • Knowledge of statistical techniques and methodologies for quality assurance • Proven experience in developing and managing quality management systems in a regulated environment • Strong understanding of global regulatory requirements, including FDA and EMA regulations • Excellent leadership and communication skills with the ability to influence and collaborate across departments • Demonstrated success in driving continuous improvement initiatives and achieving measurable results • Experience in risk management, root cause analysis, and CAPA (Corrective and Preventive Action) processes

🏖️ Benefits

• Competitive salaries • Annual performance-based bonuses • Equity-based incentive program • Generous vacation • Paid wellness days • Support for learning and development