Senior Manager, Digital Quality Management Systems, Business Analyst

BeOne Medicines

Senior Manager managing GxP digital quality systems at BeOne, ensuring alignment with quality standards and business needs. Collaborating with various departments for digital transformation and compliance enhancements.

Posted 5/12/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $133,200 - $178,200 per yearWebsite

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

system implementationbusiness analysisprocess mappingrequirements gatheringrisk assessmentproject managementdigital transformationcontinuous improvementGxP compliancevalidation practices

Soft Skills

collaborationcommunicationrelationship managementleadershipstakeholder facilitationchange managementorganizational skillsproblem-solvingadaptabilitycritical thinking

Certifications

Lean Six SigmaAgile certification