Senior Manager, Development Quality

🔥 14 minutes ago

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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

• Serve as a senior technical and operational quality leader within the Development Quality function. • Provide expert oversight of CDMO/CMO quality activities. • Lead the execution of quality management system processes. • Function as a primary quality interface with external manufacturing partners. • Bring deep radiopharmaceutical GMP expertise and independent judgment on complex quality issues. • Guide and mentor junior quality team members. • Build scalable quality processes and support IND-stage program needs across multiple country jurisdictions.

🎯 Requirements

• BS/BSc or higher in a science-related discipline required; advanced degree preferred. • 8+ years of progressive quality experience within the pharmaceutical, biotechnology, or radiopharmaceutical industry. • Direct radiopharmaceutical quality experience required, including familiarity with short half-life manufacturing. • Demonstrated expertise in independently authoring, reviewing, and approving SOPs. • Extensive experience independently reviewing and approving batch records manufactured by CMOs/CDMOs. • Expert-level experience leading investigations, root cause analysis, and CAPA management. • Applied expertise in quality risk management using ICH Q9 frameworks. • Demonstrated ability to operate as a senior quality representative in matrixed, cross-functional teams. • In-depth understanding of 21 CFR Part 210/211/212, ICH Guidelines, and USP requirements. • Radiopharmaceutical industry experience required; quality auditing experience preferred. • Ability to travel (approximately up to 20%) for CDMO/CMO audits.

🏖️ Benefits

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