BeOne Medicines USA, Inc.
Associate Director, QMS Process Improvement and Analytics(m/w/x)
Full-timeOn-siteSenior
Basel
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BEBeOne Medicines USA, Inc.
Senior Manager, Digital Quality Management Systems, Business Analyst(m/w/x)
Basel
Full-timeOn-siteManagement
Nejo AI Summary
Implementing and managing digital Quality Systems for cancer drug development. GxP compliance and validation expertise required. Hybrid work, 4-day work week option.
Requirements
- Bachelor’s degree and 7+ years Life Science, Engineering, Information Systems, or related experience in regulated life sciences environment
- Master’s degree and 5+ years Life Science, Engineering, Information Systems, or related experience in regulated life sciences environment
- Proficiency in Microsoft Office, Smartsheet, Teams, and project management tools
- 7+ years 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
- 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
Tasks
- Support strategy, implementation, and lifecycle management of digital Quality Systems
- Act as liaison between Quality, IT, and business stakeholders
- Ensure technology solutions align with business requirements and goals
- Balance QMS responsibilities with project leadership and process optimization
- Drive GxP compliance and enhance digital maturity
- Serve as business System Owner for assigned GxP digital systems
- Lead system implementations and enhancements lifecycle
- Gather and translate business needs into requirements
- Drive process mapping and continuous improvement initiatives
- Lead digital transformation initiatives across Quality
- Collaborate with QA, IT, Regulatory, Clinical, and vendors
- Align systems with business strategy
- Develop relationships with business process owners
- Ensure systems meet evolving needs
- Plan and lead UAT, training, and change management
- Manage project scope, timeline, resources, and budgets
- Escalate project issues as needed
- Ensure system compliance with GxP, FDA, EMA, and ISO standards
- Prepare and deliver project updates and communications
- Prepare and deliver system documentation
- Oversee governance and configuration of digital quality tools
- Administer digital quality tools like Veeva QMS
- Align digital quality tools with policies and compliance standards
- Optimize system functionality for user experience
- Optimize system functionality for operational efficiency
- Develop and implement master data management practices
- Ensure data accuracy, consistency, and integrity
- Facilitate informed decision-making
- Perform other assigned duties
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Microsoft Office
- Smartsheet
- Teams
- JIRA
- MS Project
- Veeva Vault
- SAP
- Veeva QMS
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BeOne Medicines USA, Inc. and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Not a perfect match?
- BeOne Medicines USA, Inc.
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BEBeOne Medicines USA, Inc.
Senior Manager, Digital Quality Management Systems, Business Analyst(m/w/x)
Basel
Full-timeOn-siteManagement
Nejo AI Summary
Implementing and managing digital Quality Systems for cancer drug development. GxP compliance and validation expertise required. Hybrid work, 4-day work week option.
Requirements
- Bachelor’s degree and 7+ years Life Science, Engineering, Information Systems, or related experience in regulated life sciences environment
- Master’s degree and 5+ years Life Science, Engineering, Information Systems, or related experience in regulated life sciences environment
- Proficiency in Microsoft Office, Smartsheet, Teams, and project management tools
- 7+ years 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
- 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
Tasks
- Support strategy, implementation, and lifecycle management of digital Quality Systems
- Act as liaison between Quality, IT, and business stakeholders
- Ensure technology solutions align with business requirements and goals
- Balance QMS responsibilities with project leadership and process optimization
- Drive GxP compliance and enhance digital maturity
- Serve as business System Owner for assigned GxP digital systems
- Lead system implementations and enhancements lifecycle
- Gather and translate business needs into requirements
- Drive process mapping and continuous improvement initiatives
- Lead digital transformation initiatives across Quality
- Collaborate with QA, IT, Regulatory, Clinical, and vendors
- Align systems with business strategy
- Develop relationships with business process owners
- Ensure systems meet evolving needs
- Plan and lead UAT, training, and change management
- Manage project scope, timeline, resources, and budgets
- Escalate project issues as needed
- Ensure system compliance with GxP, FDA, EMA, and ISO standards
- Prepare and deliver project updates and communications
- Prepare and deliver system documentation
- Oversee governance and configuration of digital quality tools
- Administer digital quality tools like Veeva QMS
- Align digital quality tools with policies and compliance standards
- Optimize system functionality for user experience
- Optimize system functionality for operational efficiency
- Develop and implement master data management practices
- Ensure data accuracy, consistency, and integrity
- Facilitate informed decision-making
- Perform other assigned duties
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- Microsoft Office
- Smartsheet
- Teams
- JIRA
- MS Project
- Veeva Vault
- SAP
- Veeva QMS
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BeOne Medicines USA, Inc. and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
BeOne Medicines USA, Inc.
Industry
Pharmaceuticals
Description
The company is focused on developing strategies to fight cancer through regulatory affairs in diagnostics and medical devices.
Not a perfect match?
- BeOne Medicines USA, Inc.
Associate Director, QMS Process Improvement and Analytics(m/w/x)
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