BeOne Medicines USA, Inc.
Associate Director, BPO Global APQR & Product Data Quality(m/w/x)
Full-timeOn-siteSenior
Basel
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Quality leadership for molecule-level governance and regulatory CMC submissions in cancer drug development. Master's degree with 10+ years experience preferred. Direct impact on life-saving cancer therapies.
Requirements
- Bachelor’s degree and 8+ years experience
- Master’s degree and 10+ years experience preferred
- 5+ years managerial or leadership experience
- Strong PC literacy and MS Office skills
- Experience in statistical modeling software
- Advanced degree in relevant field
- Extensive experience leading quality investigations
- 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 across business functions
- Willingness to travel up to 20%
Tasks
- Represent the quality organization in molecule-level governance meetings
- Facilitate quality risk assessments and complex investigations
- Review regulatory CMC submission content for accuracy
- Manage product quality network teams for clinical and commercial programs
- Embed quality considerations into new product development and lifecycles
- Advise on CMC strategies and quality risk management for commercialization
- Monitor product quality performance to identify and drive improvements
- Lead cross-functional teams to enhance global quality systems
- Implement Quality Risk Management frameworks following ICH Q9 standards
- Support regulatory inspections and audits against global standards
- Mentor team members to develop product quality and leadership skills
- Analyze emerging scientific trends and their impact on products
Work Experience
- 8 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- MS Office
- Outlook
- Word
- Excel
- PowerPoint
- 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 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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Quality leadership for molecule-level governance and regulatory CMC submissions in cancer drug development. Master's degree with 10+ years experience preferred. Direct impact on life-saving cancer therapies.
Requirements
- Bachelor’s degree and 8+ years experience
- Master’s degree and 10+ years experience preferred
- 5+ years managerial or leadership experience
- Strong PC literacy and MS Office skills
- Experience in statistical modeling software
- Advanced degree in relevant field
- Extensive experience leading quality investigations
- 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 across business functions
- Willingness to travel up to 20%
Tasks
- Represent the quality organization in molecule-level governance meetings
- Facilitate quality risk assessments and complex investigations
- Review regulatory CMC submission content for accuracy
- Manage product quality network teams for clinical and commercial programs
- Embed quality considerations into new product development and lifecycles
- Advise on CMC strategies and quality risk management for commercialization
- Monitor product quality performance to identify and drive improvements
- Lead cross-functional teams to enhance global quality systems
- Implement Quality Risk Management frameworks following ICH Q9 standards
- Support regulatory inspections and audits against global standards
- Mentor team members to develop product quality and leadership skills
- Analyze emerging scientific trends and their impact on products
Work Experience
- 8 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- MS Office
- Outlook
- Word
- Excel
- PowerPoint
- 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 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
BeOne
Industry
Pharmaceuticals
Description
BeOne is growing rapidly and seeks scientific and business professionals passionate about fighting cancer.
Not a perfect match?
- BeOne Medicines USA, Inc.
Associate Director, BPO Global APQR & Product Data Quality(m/w/x)
Full-timeOn-siteSeniorBasel - BeOne Medicines USA, Inc.
Associate Director, QMS Process Improvement and Analytics(m/w/x)
Full-timeOn-siteSeniorBasel - 1201 F. Hoffmann-La Roche AG
Principal DP (Drug Product) Product Steward - Global MSAT(m/w/x)
Full-timeOn-siteSeniorBasel - BeOne Medicines I GmbH
Director, QMS BPO, Quality Issue Escalation, Risk & Knowledge(m/w/x)
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Executive Director, Head of Quality, Europe(m/w/x)
Full-timeOn-siteSeniorBasel