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BEBeOne Medicines USA, Inc.

Associate Director, QMS Process Improvement and Analytics(m/w/x)

Basel
Full-timeOn-siteSenior
Data Science

Optimizing QMS processes and analytics for regulatory affairs in cancer diagnostics and medical devices. 8+ years progressive quality leadership experience, with 5+ years managerial, required. Direct impact on cancer treatment strategies.

Requirements

  • Bachelor’s degree and 8+ years of progressive quality leadership experience
  • Master’s degree and 6+ years of progressive quality leadership experience (preferred)
  • 5 years of managerial or leadership experience
  • Experience with matrix reporting and oversight of reports
  • Strong PC literacy and MS Office skills
  • Experience with electronic QMS systems and data analytics
  • Advanced user of Smartsheet
  • Ability to learn new digital systems
  • 8+ years of Quality Systems experience in regulated industry
  • Working knowledge of global regulatory requirements
  • Hands-on experience with QMS processes
  • Ability to lead process improvement initiatives
  • Excellent technical writing and document review skills
  • Strong analytical, problem-solving, and communication skills
  • Effective collaboration in cross-functional environments
  • Certification in Lean, Six Sigma, or similar (plus)

Tasks

  • Maintain compliant and efficient QMS processes
  • Define and analyze key performance indicators
  • Identify trends and recommend performance improvements
  • Support Quality Council and governance meetings
  • Communicate risks and required actions clearly
  • Support digital transformation and automation initiatives
  • Modernize QMS processes and data visibility
  • Enhance QMS policies and enterprise SOPs
  • Ensure documentation clarity and technical accuracy
  • Provide guidance on root cause analysis
  • Lead cross-functional QMS workflow improvement projects
  • Enhance user experience and execution quality
  • Ensure audit and inspection readiness
  • Promote alignment across various business partners

Work Experience

  • 8 years

Education

  • Bachelor's degreeOR
  • Master's degree

Languages

  • EnglishBusiness Fluent

Tools & Technologies

  • MS Office
  • Outlook
  • Word
  • Excel
  • PowerPoint
  • Veeva
  • TrackWise
  • Smartsheet
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.

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