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BEBeOne Medicines USA, Inc.

Associate Director, BPO Global APQR & Product Data Quality(m/w/x)

Basel
Full-timeOn-siteSenior
Data Science

Overseeing global APQR and product data quality for cancer diagnostics and medical devices. 3 years managerial experience required. Global process oversight, cross-functional team collaboration.

Requirements

  • Bachelor’s degree and 6+ years experience
  • Master’s degree and 8+ years experience preferred
  • 3 years managerial or leadership experience
  • Strong PC literacy and MS Office skills
  • Ability to learn specialized platforms
  • Advanced degree in life sciences
  • Experience leading quality investigations and risk management
  • Expertise in quality systems and regulations
  • Strong leadership and problem-solving skills
  • Experience developing global training programs
  • Proficiency in quality tools and methodologies
  • Effective communication of complex information

Tasks

  • Oversee the global APQR process
  • Analyze product knowledge throughout commercial lifecycles
  • Monitor process capability using statistical analysis
  • Ensure continuous process validation and improvement
  • Manage product data reliability and accessibility
  • Provide second-line technical and scientific support
  • Drive cross-functional collaboration and quality governance
  • Embed quality considerations into product development
  • Track and implement regulatory CMC commitments
  • Lead teams to address systemic quality challenges
  • Represent the quality organization in governance forums
  • Support regulatory inspections and audits
  • Mentor team members in product quality skills
  • Evaluate emerging scientific and technical trends

Work Experience

  • 6 years

Education

  • Bachelor's degreeOR
  • Master's degree

Languages

  • EnglishBusiness Fluent

Tools & Technologies

  • MS Office
  • Outlook
  • Word
  • Excel
  • PowerPoint
  • Veeva
  • Power BI
  • Calyx
  • SAP
  • Mintab
  • JMP
  • Tableau
  • SciLab
  • Lean
  • Six Sigma
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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