BeOne Medicines USA, Inc.
Associate Director, QMS Process Improvement and Analytics(m/w/x)
Full-timeOn-siteSenior
Basel
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BEBeOne Medicines I GmbH
Director, QMS BPO, Quality Issue Escalation, Risk & Knowledge(m/w/x)
Basel
from CHF 178,600 - 223,300 / year
Full-timeOn-siteSenior
Nejo AI Summary
Managing global GxP and Quality incidents for a growing oncology pharmaceutical company. 6 years of leadership experience required. 4-day work week, personal mentoring program.
Requirements
- Bachelor’s degree and 8+ years in quality sciences, systems, or related fields in regulated industry
- Master’s degree and 10+ years direct experience preferred
- 6 years managerial or team/project/program leadership experience
- Strong PC literacy; MS Office skills; ability to learn specialized platforms
- Experience with regulatory interactions and health authority communication
Tasks
- Manage global GxP and Quality incidents
- Initiate GxP/Quality incident prevention measures
- Maintain and improve incident management processes
- Ensure compliance with regulatory requirements (e.g., ICH Q9)
- Serve as SME for quality risk assessment and investigations
- Facilitate change control and resolution of complex quality issues
- Review regulatory CMC submission content
- Build and grow knowledge management processes
- Collaborate with Product Data Quality team for rapid data access
- Develop and implement GxP/Quality incident management processes
- Oversee intake, triage, investigation, documentation, and resolution of incidents
- Partner with cross-functional teams for incident management
- Conduct comprehensive root cause investigations
- Develop and oversee CAPA plans and lessons learned
- Initiate and execute market actions when necessary
- Ensure regulatory and GxP compliance for escalation and notification
- Prepare for and support inspections and audits
- Develop and deliver training on incident management
- Share lessons learned from managed incidents
- Promote a culture of quality and accountability
- Track and report on key performance indicators
- Monitor and report incident trends
Work Experience
- 8 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
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BeOne Medicines I GmbH 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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BEBeOne Medicines I GmbH
Director, QMS BPO, Quality Issue Escalation, Risk & Knowledge(m/w/x)
Basel
from CHF 178,600 - 223,300 / year
Full-timeOn-siteSenior
Nejo AI Summary
Managing global GxP and Quality incidents for a growing oncology pharmaceutical company. 6 years of leadership experience required. 4-day work week, personal mentoring program.
Requirements
- Bachelor’s degree and 8+ years in quality sciences, systems, or related fields in regulated industry
- Master’s degree and 10+ years direct experience preferred
- 6 years managerial or team/project/program leadership experience
- Strong PC literacy; MS Office skills; ability to learn specialized platforms
- Experience with regulatory interactions and health authority communication
Tasks
- Manage global GxP and Quality incidents
- Initiate GxP/Quality incident prevention measures
- Maintain and improve incident management processes
- Ensure compliance with regulatory requirements (e.g., ICH Q9)
- Serve as SME for quality risk assessment and investigations
- Facilitate change control and resolution of complex quality issues
- Review regulatory CMC submission content
- Build and grow knowledge management processes
- Collaborate with Product Data Quality team for rapid data access
- Develop and implement GxP/Quality incident management processes
- Oversee intake, triage, investigation, documentation, and resolution of incidents
- Partner with cross-functional teams for incident management
- Conduct comprehensive root cause investigations
- Develop and oversee CAPA plans and lessons learned
- Initiate and execute market actions when necessary
- Ensure regulatory and GxP compliance for escalation and notification
- Prepare for and support inspections and audits
- Develop and deliver training on incident management
- Share lessons learned from managed incidents
- Promote a culture of quality and accountability
- Track and report on key performance indicators
- Monitor and report incident trends
Work Experience
- 8 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
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of BeOne Medicines I GmbH 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 Medicines I GmbH
Industry
Pharmaceuticals
Description
The company is focused on fighting cancer and offers opportunities for scientific and business professionals.
Not a perfect match?
- BeOne Medicines USA, Inc.
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