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Associate Director, BPO Global APQR & Product Data Quality(m/w/x)
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
- English – Business Fluent
Tools & Technologies
- MS Office
- Outlook
- Word
- Excel
- PowerPoint
- Veeva
- Power BI
- Calyx
- SAP
- Mintab
- JMP
- Tableau
- SciLab
- Lean
- Six Sigma
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Associate Director, BPO Global APQR & Product Data Quality(m/w/x)
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
- English – Business Fluent
Tools & Technologies
- MS Office
- Outlook
- Word
- Excel
- PowerPoint
- Veeva
- Power BI
- Calyx
- SAP
- Mintab
- JMP
- Tableau
- SciLab
- Lean
- Six Sigma
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
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?
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