Sanofi-Aventis Deutschland GmbH
Quality Contamination Control Manager(m/w/x)
Full-timeOn-siteSenior
Frankfurt am Main
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SASanofi-Aventis Deutschland GmbH
Quality Lead(m/w/x)
Frankfurt am Main
from 113,760 - 151,680 / year
Full-timeOn-siteSenior
Nejo AI Summary
Leading Quality Assurance for IFF project, ensuring GMP and BLA compliance. PhD-level qualification in Science strongly preferred. Company employee benefit programs.
Requirements
- Degree in Science, Pharmacy, or equivalent
- PhD-level qualification in Science strongly preferred
- Several years of industry experience in biopharma or related regulated industry
- Relevant experience in leadership quality positions
- Demonstrated leadership experience in quality role for capital investment program in PharmaBiotech
- In-depth knowledge of biologic product license application processes and regulatory requirements (FDA, Annex I, BLA)
- Strong understanding of pharmaceutical manufacturing processes, particularly large-scale biologics plants for bacterial processes
- Effective coaching skills for people development and performance improvement
- Visionary leadership to inspire quality culture across large, cross-functional teams
- Excellent communication and business partnering capabilities
- Expertise in Quality Risk Management, Quality Systems, and continuous improvement methodologies
- Strong interpersonal skills for multicultural, international environment
- Fluency in English required
- German and/or French highly advantageous
Tasks
- Lead Quality Assurance functions for IFF project
- Ensure compliance with Sanofi standards, GMP, BLA, and Annex I
- Develop and implement C&Q&V strategies and plans
- Manage DQ, SAT, FAT, IQ, OQ, and nP-PQ protocols
- Prepare final CQ reports and Validation Master Plan
- Serve as Quality focal point in Frankfurt
- Integrate quality requirements with Frankfurt Bio Campus
- Drive quality culture and GMP compliance performance
- Promote continuous improvement across all functions
- Manage proactive and reactive Quality Risk Management
- Represent project as primary quality escalation point
- Operate Quality Assurance, Quality Control, and Quality Systems
- Support Qualified Persons and Regulatory Affairs
- Develop and mentor IFF Quality team
- Manage IFF quality budget and schedule
- Optimize cost and schedule decisions
- Develop synergies with Frankfurt Bio Campus and Insulin Facility Beijing
- Contribute to digital transformation strategy
- Implement MES, batch review by exception, and SMART factory initiatives
- Communicate and escalate quality issues effectively
- Update and promote Sanofi Global Quality Documentation
- Maintain IFF GOPs and global procedures
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Native
- German – Basic
- French – Basic
Benefits
Corporate Discounts
- Company employee benefit programs
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Sanofi-Aventis Deutschland 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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SASanofi-Aventis Deutschland GmbH
Quality Lead(m/w/x)
Frankfurt am Main
from 113,760 - 151,680 / year
Full-timeOn-siteSenior
Nejo AI Summary
Leading Quality Assurance for IFF project, ensuring GMP and BLA compliance. PhD-level qualification in Science strongly preferred. Company employee benefit programs.
Requirements
- Degree in Science, Pharmacy, or equivalent
- PhD-level qualification in Science strongly preferred
- Several years of industry experience in biopharma or related regulated industry
- Relevant experience in leadership quality positions
- Demonstrated leadership experience in quality role for capital investment program in PharmaBiotech
- In-depth knowledge of biologic product license application processes and regulatory requirements (FDA, Annex I, BLA)
- Strong understanding of pharmaceutical manufacturing processes, particularly large-scale biologics plants for bacterial processes
- Effective coaching skills for people development and performance improvement
- Visionary leadership to inspire quality culture across large, cross-functional teams
- Excellent communication and business partnering capabilities
- Expertise in Quality Risk Management, Quality Systems, and continuous improvement methodologies
- Strong interpersonal skills for multicultural, international environment
- Fluency in English required
- German and/or French highly advantageous
Tasks
- Lead Quality Assurance functions for IFF project
- Ensure compliance with Sanofi standards, GMP, BLA, and Annex I
- Develop and implement C&Q&V strategies and plans
- Manage DQ, SAT, FAT, IQ, OQ, and nP-PQ protocols
- Prepare final CQ reports and Validation Master Plan
- Serve as Quality focal point in Frankfurt
- Integrate quality requirements with Frankfurt Bio Campus
- Drive quality culture and GMP compliance performance
- Promote continuous improvement across all functions
- Manage proactive and reactive Quality Risk Management
- Represent project as primary quality escalation point
- Operate Quality Assurance, Quality Control, and Quality Systems
- Support Qualified Persons and Regulatory Affairs
- Develop and mentor IFF Quality team
- Manage IFF quality budget and schedule
- Optimize cost and schedule decisions
- Develop synergies with Frankfurt Bio Campus and Insulin Facility Beijing
- Contribute to digital transformation strategy
- Implement MES, batch review by exception, and SMART factory initiatives
- Communicate and escalate quality issues effectively
- Update and promote Sanofi Global Quality Documentation
- Maintain IFF GOPs and global procedures
Work Experience
- approx. 4 - 6 years
Education
- Bachelor's degree
Languages
- English – Native
- German – Basic
- French – Basic
Benefits
Corporate Discounts
- Company employee benefit programs
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Sanofi-Aventis Deutschland 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
Sanofi-Aventis Deutschland GmbH
Industry
Pharmaceuticals
Description
Das Unternehmen bietet Arzneimittel zur Prävention von Herz-Kreislauf-Erkrankungen an und setzt sich für die Verbesserung der Lebensqualität ein.
Not a perfect match?
- Sanofi-Aventis Deutschland GmbH
Quality Contamination Control Manager(m/w/x)
Full-timeOn-siteSeniorFrankfurt am Main - Sanofi-Aventis Deutschland GmbH
Product Lead NLP(m/w/x)
Full-timeTemporary contractOn-siteSeniorFrankfurt am Main - Sanofi-Aventis Deutschland GmbH
Qualified Person / Batch Release Lead(m/w/x)
Full-timeOn-siteExperiencedFrankfurt am Main - Sanofi-Aventis Deutschland GmbH
Laboratory Head non-GMP PP Tech Area(m/w/x)
Full-timeOn-siteSeniorFrankfurt am Main - Sanofi-Aventis Deutschland GmbH
Lead Regulatory Site Officer InsuLINK(m/w/x)
Full-timeOn-siteManagementFrankfurt am Main