Senior Manager, Digital Quality Management Systems, Business Analyst
BeOne Medicines
full-time
Posted on:
Location Type: Remote
Location: Netherlands
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Job Level
Tech Stack
About the role
- 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, ensuring alignment with organizational policies and compliance standards while optimizing system functionality to enhance user experience and operational efficiency
- Develop and implement master data management practices to ensure data accuracy, consistency, and integrity across digital quality tools, facilitating informed decision-making and compliance with regulatory requirements
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
- Lean Six Sigma or Agile certification preferred
Benefits
- Health insurance
- Retirement plans
- Professional development opportunities
- Flexible work arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
system implementationprocess mappingdata managementproject managementrequirements gatheringchange managementUAT planningdigital transformationcontinuous improvementsystem compliance
Soft Skills
collaborationrelationship managementcommunicationleadershipproblem-solvingorganizational skillsstakeholder engagementadaptabilitycritical thinkingdecision-making
Certifications
Lean Six SigmaAgile certification