Dein persönlicher KI-Karriere-Agent
(Senior) Manager Operational Quality Assurance(m/w/x)
Overseeing operational quality assurance for drug products, managing deviation and CAPA systems in Jira. Scientific studies in Pharmacy, Chemistry, or related field required. Hybrid work, attractive location.
Anforderungen
- Scientific studies in Pharmacy, Chemistry or related field
- First leadership experience in Quality Assurance (advantageous)
- Good knowledge of cGMP (EU, FDA), GDP and change control
- Proficiency in Microsoft Office, database queries, QM and SOP systems
- Knowledge of national/international drug product requirements
- Knowledge of medical device requirements (advantageous)
- Analytical thinking and understanding complex matters
- Team-oriented, proactive organizational talent
- Strong communication and problem-solving skills
- Confident appearance
- Excellent verbal and written communication in German and English
Aufgaben
- Maintain and develop operational quality assurance for drug products
- Organize, monitor, and develop deviation and CAPA systems
- Manage process deviations and CAPAs in Jira
- Ensure timely resolution of deviations and CAPAs
- Manage training administration for Therapeutics Operations
- Maintain document management in Smartsolve
- Maintain product documentation for process, transport, and method validation
- Prepare Product Quality Reviews (PQRs) for drug products
- Support authority and customer inspections
- Present relevant QA activities
- Serve as subject matter contact for deviations, CAPAs, and training
- Act as contact person for internal and external stakeholders
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- cGMP
- GDP
- Microsoft Office
- SOP systems
Benefits
Karriere- und Weiterentwicklung
- Individual career development
Flexibles Arbeiten
- Hybrid work model
Familienfreundlichkeit
- Good work-life balance
Sonstige Vorteile
- Attractive location
Parkplatz & Pendelvorteile
- Good transport links
Modernes Büro
- Modern workplaces
Gratis oder Vergünstigte Mahlzeiten
- Company restaurant
Lockere Unternehmenskultur
- Global family business
- Flat hierarchies
- Open, respectful corporate culture
Gesundheits- & Fitnessangebote
- WellPass
Öffi Tickets
- Deutschland-Ticket
Mitarbeiterrabatte
- Corporate Benefits
Firmenfahrrad
- JobBike
Noch nicht perfekt?
- IQVIAVollzeitRemoteManagementFrankfurt am Main
- Merz Therapeutics
Global Lead Medical Affairs Operations & Excellence(m/w/x)
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Vollzeit/Teilzeitmit HomeofficeBerufserfahrenNeu-Isenburg - Fresenius Medical Care D. GmbH
Head of Design Quality Assurance(m/w/x)
Vollzeitmit HomeofficeSeniorBad Homburg vor der Höhe - Sanofi-Aventis Deutschland GmbH
Regulatory Site Officer(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenFrankfurt am Main
(Senior) Manager Operational Quality Assurance(m/w/x)
Overseeing operational quality assurance for drug products, managing deviation and CAPA systems in Jira. Scientific studies in Pharmacy, Chemistry, or related field required. Hybrid work, attractive location.
Anforderungen
- Scientific studies in Pharmacy, Chemistry or related field
- First leadership experience in Quality Assurance (advantageous)
- Good knowledge of cGMP (EU, FDA), GDP and change control
- Proficiency in Microsoft Office, database queries, QM and SOP systems
- Knowledge of national/international drug product requirements
- Knowledge of medical device requirements (advantageous)
- Analytical thinking and understanding complex matters
- Team-oriented, proactive organizational talent
- Strong communication and problem-solving skills
- Confident appearance
- Excellent verbal and written communication in German and English
Aufgaben
- Maintain and develop operational quality assurance for drug products
- Organize, monitor, and develop deviation and CAPA systems
- Manage process deviations and CAPAs in Jira
- Ensure timely resolution of deviations and CAPAs
- Manage training administration for Therapeutics Operations
- Maintain document management in Smartsolve
- Maintain product documentation for process, transport, and method validation
- Prepare Product Quality Reviews (PQRs) for drug products
- Support authority and customer inspections
- Present relevant QA activities
- Serve as subject matter contact for deviations, CAPAs, and training
- Act as contact person for internal and external stakeholders
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- cGMP
- GDP
- Microsoft Office
- SOP systems
Benefits
Karriere- und Weiterentwicklung
- Individual career development
Flexibles Arbeiten
- Hybrid work model
Familienfreundlichkeit
- Good work-life balance
Sonstige Vorteile
- Attractive location
Parkplatz & Pendelvorteile
- Good transport links
Modernes Büro
- Modern workplaces
Gratis oder Vergünstigte Mahlzeiten
- Company restaurant
Lockere Unternehmenskultur
- Global family business
- Flat hierarchies
- Open, respectful corporate culture
Gesundheits- & Fitnessangebote
- WellPass
Öffi Tickets
- Deutschland-Ticket
Mitarbeiterrabatte
- Corporate Benefits
Firmenfahrrad
- JobBike
Über das Unternehmen
Merz Therapeutics
Branche
Pharmaceuticals
Beschreibung
Das Unternehmen ist ein führendes Pharma-Unternehmen, das Menschen mit Bewegungsstörungen und anderen gesundheitlichen Beschwerden hilft.
Noch nicht perfekt?
- IQVIA
Associate Manager or Manager, Clinical Operations(m/w/x)
VollzeitRemoteManagementFrankfurt am Main - Merz Therapeutics
Global Lead Medical Affairs Operations & Excellence(m/w/x)
Vollzeitmit HomeofficeSeniorFrankfurt am Main - GBG Forschungs GmbH
Quality Manager(m/w/x)
Vollzeit/Teilzeitmit HomeofficeBerufserfahrenNeu-Isenburg - Fresenius Medical Care D. GmbH
Head of Design Quality Assurance(m/w/x)
Vollzeitmit HomeofficeSeniorBad Homburg vor der Höhe - Sanofi-Aventis Deutschland GmbH
Regulatory Site Officer(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenFrankfurt am Main