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Associate Director, QMS Process Improvement and Analytics(m/w/x)
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
- English – Business Fluent
Tools & Technologies
- MS Office
- Outlook
- Word
- Excel
- PowerPoint
- Veeva
- TrackWise
- Smartsheet
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Associate Director, QMS Process Improvement and Analytics(m/w/x)
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
- English – Business Fluent
Tools & Technologies
- MS Office
- Outlook
- Word
- Excel
- PowerPoint
- Veeva
- TrackWise
- Smartsheet
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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