Boehringer Ingelheim
CMO Quality Assurance Manager(m/w/x)
Full-timeOn-siteExperienced
Ingelheim am Rhein
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BOBoehringer Ingelheim
.CMO Quality Assurance Manager(m/w/x)
Ingelheim am Rhein
Full-timeOn-siteExperienced
Nejo AI Summary
Overseeing end-to-end quality management for veterinary medicinal products and APIs at a global animal health company. Expert knowledge of FDA and EMA regulations required. Preferential consideration for severely disabled applicants.
Requirements
- Master’s degree in Pharmacy, Chemistry or Engineering
- Expert knowledge of global quality requirements (FDA and EMA regulations)
- Excellent interpersonal, communication and negotiation skills
- Ability to oversee multiple projects simultaneously
- Solid analytical skills and problem-solving ability
- Willingness for national and international business trips
- Fluent English
- German, French or Spanish beneficial
- Consideration for severely disabled applicants
Tasks
- Ensure end-to-end Quality Management for CMOs, Suppliers, and products
- Maintain compliance with regulatory requirements and BI corporate standards
- Drive continuous improvement of the Quality Management System
- Manage PQRs, change controls, deviations, CAPAs, stability monitoring, audits, complaints, QAAs, CMO ratings, risk management, and product extensions
- Prevent and resolve quality issues
- Escalate conflicts to the 3PQM EU Head
- Minimize risks and ensure timely resolutions
- Manage KPIs, conduct investigations, audits, recalls, change controls, and effectiveness checks
- Foster and improve Quality Culture within CMOs
- Conduct Quality Management Reviews
- Organize training sessions
- Perform technical visits
- Facilitate periodic meetings
- Support Quality Audits
- Collaborate with Supply Chain, CMO Management, and Regulatory Affairs
- Assist with regulatory agency interactions (e.g., FDA, EMA)
- Recommend product release or rejection
- Advise on halting production to ensure compliance and quality
- Manage multiple parallel topics with conflicting priorities
- Collaborate with various internal and external stakeholders
Work Experience
- approx. 1 - 4 years
Education
- Master's degree
Languages
- English – Native
- German – Basic
- French – Basic
- Spanish – Basic
Tools & Technologies
- FDA regulations
- EMA regulations
Benefits
Purpose-Driven Work
- Preferential consideration for severely disabled applicants
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Boehringer Ingelheim 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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BOBoehringer Ingelheim
.CMO Quality Assurance Manager(m/w/x)
Ingelheim am Rhein
Full-timeOn-siteExperienced
Nejo AI Summary
Overseeing end-to-end quality management for veterinary medicinal products and APIs at a global animal health company. Expert knowledge of FDA and EMA regulations required. Preferential consideration for severely disabled applicants.
Requirements
- Master’s degree in Pharmacy, Chemistry or Engineering
- Expert knowledge of global quality requirements (FDA and EMA regulations)
- Excellent interpersonal, communication and negotiation skills
- Ability to oversee multiple projects simultaneously
- Solid analytical skills and problem-solving ability
- Willingness for national and international business trips
- Fluent English
- German, French or Spanish beneficial
- Consideration for severely disabled applicants
Tasks
- Ensure end-to-end Quality Management for CMOs, Suppliers, and products
- Maintain compliance with regulatory requirements and BI corporate standards
- Drive continuous improvement of the Quality Management System
- Manage PQRs, change controls, deviations, CAPAs, stability monitoring, audits, complaints, QAAs, CMO ratings, risk management, and product extensions
- Prevent and resolve quality issues
- Escalate conflicts to the 3PQM EU Head
- Minimize risks and ensure timely resolutions
- Manage KPIs, conduct investigations, audits, recalls, change controls, and effectiveness checks
- Foster and improve Quality Culture within CMOs
- Conduct Quality Management Reviews
- Organize training sessions
- Perform technical visits
- Facilitate periodic meetings
- Support Quality Audits
- Collaborate with Supply Chain, CMO Management, and Regulatory Affairs
- Assist with regulatory agency interactions (e.g., FDA, EMA)
- Recommend product release or rejection
- Advise on halting production to ensure compliance and quality
- Manage multiple parallel topics with conflicting priorities
- Collaborate with various internal and external stakeholders
Work Experience
- approx. 1 - 4 years
Education
- Master's degree
Languages
- English – Native
- German – Basic
- French – Basic
- Spanish – Basic
Tools & Technologies
- FDA regulations
- EMA regulations
Benefits
Purpose-Driven Work
- Preferential consideration for severely disabled applicants
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Boehringer Ingelheim 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
Boehringer Ingelheim
Industry
Pharmaceuticals
Description
The company is focused on delivering lasting value to patients through innovative therapies and early clinical development.
Not a perfect match?
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