BeOne Medicines

Cancer has no borders. Neither do we.

Senior Manager, Digital Quality Management Systems, Business Analyst

Business AnalystBusiness AnalystFull TimeRemoteTeam 10,001+Since 2010H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

27 days ago

Salary

$133.2K - $178.2K / year

Bachelor Degree7 yrs expEnglishVault

Job 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 and ensure systems meet evolving needs • Plan and lead UAT, training, and change management activities for new system features or implementations • Manage project scope, timeline, resources, budgets, and risks, escalating issues as needed • 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 • Develop and implement master data management practices to ensure data accuracy, consistency, and integrity across digital quality tools

Job 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)
  • 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
  • Excellent interpersonal, communication, and organizational skills.
  • Lean Six Sigma or Agile certification preferred.

Benefits

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

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