IQVIA
Associate Manager or Manager, Clinical Operations(m/w/x)
Full-timeRemoteManagement
Frankfurt am Main
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MEMerz Therapeutics
(Senior) Manager Operational Quality Assurance(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 years
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- cGMP
- GDP
- Microsoft Office
- SOP systems
Benefits
Career Advancement
- Individual career development
Flexible Working
- Hybrid work model
Family Support
- Good work-life balance
Other Benefits
- Attractive location
Parking & Commuter Benefits
- Good transport links
Modern Office
- Modern workplaces
Free or Subsidized Food
- Company restaurant
Informal Culture
- Global family business
- Flat hierarchies
- Open, respectful corporate culture
Healthcare & Fitness
- WellPass
Public Transport Subsidies
- Deutschland-Ticket
Corporate Discounts
- Corporate Benefits
Company Bike
- JobBike
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Merz Therapeutics 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.
Not a perfect match?
- Merz Therapeutics
Global Lead Medical Affairs Operations & Excellence(m/w/x)
Full-timeWith HomeofficeSeniorFrankfurt am Main - Fresenius Medical Care D. GmbH
Head of Design Quality Assurance(m/w/x)
Full-timeWith HomeofficeSeniorBad Homburg vor der Höhe - GBG Forschungs GmbH
Quality Manager(m/w/x)
Full-time/Part-timeWith HomeofficeExperiencedNeu-Isenburg - ALTEN
GMP Specialist(m/w/x)
Full-timeWith HomeofficeExperiencedFrankfurt am Main
MEMerz Therapeutics
(Senior) Manager Operational Quality Assurance(m/w/x)
Frankfurt am Main
Full-timeWith Home OfficeSenior
Nejo AI Summary
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.
Requirements
- 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
Tasks
- 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
Work Experience
- 5 years
Education
- Master's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- cGMP
- GDP
- Microsoft Office
- SOP systems
Benefits
Career Advancement
- Individual career development
Flexible Working
- Hybrid work model
Family Support
- Good work-life balance
Other Benefits
- Attractive location
Parking & Commuter Benefits
- Good transport links
Modern Office
- Modern workplaces
Free or Subsidized Food
- Company restaurant
Informal Culture
- Global family business
- Flat hierarchies
- Open, respectful corporate culture
Healthcare & Fitness
- WellPass
Public Transport Subsidies
- Deutschland-Ticket
Corporate Discounts
- Corporate Benefits
Company Bike
- JobBike
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Merz Therapeutics 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
Merz Therapeutics
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein führendes Pharma-Unternehmen, das Menschen mit Bewegungsstörungen und anderen gesundheitlichen Beschwerden hilft.
Not a perfect match?
- IQVIA
Associate Manager or Manager, Clinical Operations(m/w/x)
Full-timeRemoteManagementFrankfurt am Main - Merz Therapeutics
Global Lead Medical Affairs Operations & Excellence(m/w/x)
Full-timeWith HomeofficeSeniorFrankfurt am Main - Fresenius Medical Care D. GmbH
Head of Design Quality Assurance(m/w/x)
Full-timeWith HomeofficeSeniorBad Homburg vor der Höhe - GBG Forschungs GmbH
Quality Manager(m/w/x)
Full-time/Part-timeWith HomeofficeExperiencedNeu-Isenburg - ALTEN
GMP Specialist(m/w/x)
Full-timeWith HomeofficeExperiencedFrankfurt am Main