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Microbiology Quality Control Manager(m/w/x)
Leading a lab team ensuring quality control for cardiovascular pharmaceuticals. MSc/PhD in natural sciences and proven leadership experience required. Mentoring and succession planning focus.
Anforderungen
- MSc, PhD, or equivalent in natural sciences
- Ideally Microbiology or Pharmacy specialization
- Leadership experience with proven delivery track record
- Significant industry experience
- Experience in Microbiology QC or Sterility Assurance
- Knowledge of biologic product license application
- Knowledge of Annex 1 regulatory requirements
- Leadership and assertiveness skills
- Knowledge of Quality systems and Risk Management
- Knowledge of GxP and health regulations
- International and FDA exposure
- Proficiency in German and English
Aufgaben
- Lead the microbiology quality control lab team
- Provide training, mentoring, and development for staff
- Manage succession planning for key positions
- Offer strategic guidance on quality control policies
- Deliver lab project goals within budget and schedule
- Coordinate internal and external expert teams
- Ensure compliance with company standards and good practices
- Report regularly to the global project leadership
- Maintain method development, validation, and transfer
- Execute commissioning, qualification, and validation strategies
- Oversee lab readiness across all project phases
- Collaborate with international sites to share best practices
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Abgeschlossene Berufsausbildung
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- Quality systems
- Quality Risk Management
- GxP
- FDA regulations
- Annex 1
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Microbiology Quality Control Manager(m/w/x)
Leading a lab team ensuring quality control for cardiovascular pharmaceuticals. MSc/PhD in natural sciences and proven leadership experience required. Mentoring and succession planning focus.
Anforderungen
- MSc, PhD, or equivalent in natural sciences
- Ideally Microbiology or Pharmacy specialization
- Leadership experience with proven delivery track record
- Significant industry experience
- Experience in Microbiology QC or Sterility Assurance
- Knowledge of biologic product license application
- Knowledge of Annex 1 regulatory requirements
- Leadership and assertiveness skills
- Knowledge of Quality systems and Risk Management
- Knowledge of GxP and health regulations
- International and FDA exposure
- Proficiency in German and English
Aufgaben
- Lead the microbiology quality control lab team
- Provide training, mentoring, and development for staff
- Manage succession planning for key positions
- Offer strategic guidance on quality control policies
- Deliver lab project goals within budget and schedule
- Coordinate internal and external expert teams
- Ensure compliance with company standards and good practices
- Report regularly to the global project leadership
- Maintain method development, validation, and transfer
- Execute commissioning, qualification, and validation strategies
- Oversee lab readiness across all project phases
- Collaborate with international sites to share best practices
Berufserfahrung
- ca. 4 - 6 Jahre
Ausbildung
- Abgeschlossene Berufsausbildung
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- Quality systems
- Quality Risk Management
- GxP
- FDA regulations
- Annex 1
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Sanofi-Aventis Deutschland GmbH
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen bietet Arzneimittel zur Prävention von Herz-Kreislauf-Erkrankungen an und setzt sich für die Verbesserung der Lebensqualität ein.
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