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BE
BeOne Medicines USA, Inc.
7d ago

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

Basel
Full-timeOn-siteSenior
Data Science

Description

You will drive the company's quality standards by modernizing QMS processes and leading digital initiatives to ensure compliance, technical accuracy, and continuous operational improvement.

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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)

Education

Bachelor's degree
OR
Master's degree

Work Experience

8 years

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

Tools & Technologies

MS OfficeOutlookWordExcelPowerPointVeevaTrackWiseSmartsheet

Languages

EnglishBusiness Fluent

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