Director, QMS BPO, Quality Issue Escalation, Risk & Knowledge Management

🕒 June 2

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BeOne Medicines

10,000+ employees

Founded 2010

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Managing assigned escalated GxP and Quality incidents in an end-to-end process on global level • Initiating GxP/Quality incident prevention measures • Maintaining (incl continuous improvement) of defined incident management related processes within regulated environments on global level • Leading and overseeing that quality incidents are managed effectively • Ensuring compliance with regulatory requirements (e.g., ICH Q9) • Building and growing the knowledge management processes and tools to enable rapid access to data and knowledge over the entire product lifecycle

🎯 Requirements

• Bachelor’s degree and 8+ years of experience in quality sciences, quality systems, or related fields within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices) • Master’s degree and 10+ years direct experience preferred • 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources • Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint) • Experience with regulatory interactions including notification and communication with health authorities on global level for sensitive compliance topics

🏖️ Benefits

• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness

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