Quality Manager Technical Development (f/m/d)

Design. Progress. Together.

 

CureVac AG is a global biopharmaceutical company researching and developing novel drugs based on the natural molecule Messenger RNA (mRNA). Our focus is on prophylactic vaccines, innovative cancer immunotherapies and protein-based therapies. Currently, all RNA people are striving to achieve our main goal: To bring multiple best-in-class mRNA drugs to market.

 

To strengthen our team in Tübingen near Stuttgart, we are currently looking to recruit a

 

Quality Manager Technical Development (f/m/d)

 

Your responsibilities:

 

  • Finalize, revise and update SOPs in the area of Quality in development regarding Quality Target Product Profile (QTPP) and Drug Development Guideline (DDG) processes & their description
  • Create and maintain SOPs of End-to-end process flow from TPP downstream to Manufacturing Authorization of Commercial medicinal product via transfer (scale-up) and Process Performance Qualification (PPQ) runs and define deliverables
  • Formalize processes and get final approvals by all stakeholders
  • Create, circulate, and approve SOP, based on feedback of stakeholders
  • Start establishing SOP training materials 
  • Define how to track any input to create and later to change parameters in QTPP and other End-to-End Processes
  • Create QTPP history file electronically by participating in digitization projects of quality processes
  • Alignment and integration of the QTPP process with DDG/TDG
  • Matching End-to-end process flow with required documents for documentation of the development history and prepare signing-off the accomplishment of each stage gate review
  • Support Development programs regarding QTPP perspective to ensure adherence to the QTPP and if needed initiate changes
  • Foster and govern Quality of TechDev in- and output and its adherence to QTPP and DDG

 

Your qualifications:

 

  • Master or PhD. degree in in the field of biotechnology, pharmacy or chemistry, or a comparable qualification
  • several years of professional quality management experience in the (bio)pharmaceutical industry
  • Experience in pharmaceutical-related regulated development and preferably CMC area
  • Technical expertise in manufacturing, and technical development is a plus
  • Proven experience in working cross functionally, leveraging their skills to influence and drive results within the matrix organization
  • High self-steering capabilities and a structured way of working in a dynamic environment
  • Exceptional team player and ability to develop strong network across the company
  • Project Management skills
  • Fluency in English and German

 

We offer you a challenging and varied opportunity with an innovative and dynamic company that is expanding.
With much passion and sense of responsibility, we work together on the medical revolution. We pride ourselves on maintaining an honest and trusting relationship with each other which is characterized by openness to new ideas and continuous progress. Mutual respect, reliability and personal initiative are self-evident for us.

Design your future with us – become part of the RNA people!   

We look forward to receiving your application via our CareerPortal.

 

CureVac AG

 

Human Resources
Gregor Zimmermann 
Friedrich-Miescher-Straße 15
72076 Tübingen