Senior Manager, Digital Quality Management Systems, Business Analyst

🕒 May 12

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BeOne Medicines

WebsiteLinkedInAll Job Openings

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

• Serve as the business System Owner for assigned Quality GxP digital systems (e.g., eQMS, QualityDocs, etc) • Lead and manage full lifecycle of system implementations and enhancements • Gather and translate complex business needs into functional and technical requirements • Drive process mapping, continuous improvement, and digital transformation initiatives across Quality • Collaborate with cross-functional teams including QA, IT, Regulatory, Clinical, and external vendors to align systems with business strategy • Develop and maintain strong relationships with business process owners • Plan and lead UAT, training, and change management activities for new system features or implementations • Manage project scope, timeline, resources, budgets, and risks • Ensure ongoing system compliance with applicable GxP, FDA, EMA, and ISO standards • Prepare and deliver high-quality project updates, stakeholder communications, and system documentation • Oversee the governance, configuration, and administration of digital quality tools such as Veeva QMS

🎯 Requirements

• Bachelor’s degree and 7+ years of Life Science, Engineering, Information Systems, or related experience in a regulated life sciences environment required • Master’s degree and 5+ years of Life Science, Engineering, Information Systems, or related experience in a regulated life sciences environment preferred • Proficient in Microsoft Office, Smartsheet, Teams, and project management tools (e.g., JIRA, MS Project) • 7+ years of related experience in Quality Systems, project management, and business analysis • Strong understanding of GxP requirements, Quality System Regulations (QSR), and validation practices • Proven experience managing enterprise system implementations (e.g., Veeva Vault, SAP, etc.) • Experience in business administration for Veeva QMS • Skilled in process modeling, requirements gathering, risk assessment, and stakeholder facilitation • Lean Six Sigma or Agile certification preferred.

🏖️ Benefits

• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness • Discretionary equity awards • Employee Stock Purchase Plan