Sobi
External Quality Operation Manager (EQOM)(m/w/x)
Full-timeWith HomeofficeSenior
Basel
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BEBeOne Medicines I GmbH
Associate Director, External Supply Quality Europe(m/w/x)
Basel
Full-timeWith Home OfficeManagement
Nejo AI Summary
Leading Small Molecule commercial product quality team, overseeing European CMO performance management. 6+ years managerial experience and in-depth GMP in quality/manufacturing required. European travel expected.
Requirements
- 6+ years of managerial experience
- Ability to lead teams and manage staff
- Strong PC literacy; MS Office skills
- In-depth GMP experience in quality and manufacturing
- Ability to apply logical and scientific thinking
- Inspiring and encouraging team members
Tasks
- Lead the Small Molecule commercial product quality team
- Ensure compliance with regulatory requirements and BeOne standards
- Oversee BeOne qualified CMO performance management in Europe
- Evaluate trends and implement remediation as needed
- Act as the primary escalation point for CMO quality managers
- Review and approve change control strategies for CMO changes
- Manage APQR activities for CMO manufactured BeOne products
- Handle batch-related deviations and implement effective CAPAs at CMO
- Perform PIP (Person in Plant) activities
- Oversee inspection management for successful CMO and BeOne inspections
- Ensure quality processes meet Health Authorities' expectations
- Advise on Quality Agreement content and updates
- Collaborate cross-functionally with Manufacturing, Supply Chain, and Regulatory CMC
- Ensure timely batch release for commercial product supply
- Support product recalls from the commercial supply chain when necessary
- Author Standard Operating Procedures for the department
Work Experience
- 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- MS Office
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
Associate Director, External Supply Quality Europe(m/w/x)
Basel
Full-timeWith Home OfficeManagement
Nejo AI Summary
Leading Small Molecule commercial product quality team, overseeing European CMO performance management. 6+ years managerial experience and in-depth GMP in quality/manufacturing required. European travel expected.
Requirements
- 6+ years of managerial experience
- Ability to lead teams and manage staff
- Strong PC literacy; MS Office skills
- In-depth GMP experience in quality and manufacturing
- Ability to apply logical and scientific thinking
- Inspiring and encouraging team members
Tasks
- Lead the Small Molecule commercial product quality team
- Ensure compliance with regulatory requirements and BeOne standards
- Oversee BeOne qualified CMO performance management in Europe
- Evaluate trends and implement remediation as needed
- Act as the primary escalation point for CMO quality managers
- Review and approve change control strategies for CMO changes
- Manage APQR activities for CMO manufactured BeOne products
- Handle batch-related deviations and implement effective CAPAs at CMO
- Perform PIP (Person in Plant) activities
- Oversee inspection management for successful CMO and BeOne inspections
- Ensure quality processes meet Health Authorities' expectations
- Advise on Quality Agreement content and updates
- Collaborate cross-functionally with Manufacturing, Supply Chain, and Regulatory CMC
- Ensure timely batch release for commercial product supply
- Support product recalls from the commercial supply chain when necessary
- Author Standard Operating Procedures for the department
Work Experience
- 6 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- MS Office
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.
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.
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