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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.
Anforderungen
- 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)
Aufgaben
- 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
Berufserfahrung
- 8 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- 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.
Anforderungen
- 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)
Aufgaben
- 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
Berufserfahrung
- 8 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- MS Office
- Outlook
- Word
- Excel
- PowerPoint
- Veeva
- TrackWise
- Smartsheet
Über das Unternehmen
BeOne Medicines USA, Inc.
Branche
Pharmaceuticals
Beschreibung
The company is focused on developing strategies to fight cancer through regulatory affairs in diagnostics and medical devices.
Noch nicht perfekt?
- BeOne Medicines USA, Inc.
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Director, Product Quality Lead(m/w/x)
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Associate Director, Good Clinical Practice (GCP) Audit and Vendor Management(m/w/x)
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