- For our R&D Quality Management in Marburg we are currently looking for a:
- Senior Manager, R&D Quality (m/f/d) - R-229349
(fulltime / unlimited / non-tariff Level 7/ Expiration Date: 07.05.2024)
What you can expect: - Manage integration of R&D quality systems, policies and procedures in line with CSL Global Quality Management System (QMS) for Product Development
- Develop and maintain Phase appropriate Quality systems
- Provide Quality overisght to the Product Development organisation for New Product Introduction, encompassing CSL and CMO manufactured and tested clincial material for Phase 1 & 2 and Phase 3 (where determined)
- Primary representative for R&D Quality in site quality management forums and discussions
- Manage the R&D quality unit to provide change control, batch technical release, deviation management and risk management functions for Product Development in Marburg and Bern
- Provide QA disposition on R&D deviations/CAPAs and Investigations for R&D clinical materials
- Accountable for the QA team for the technical review and disposition of non- clinical toxicological material and clinical material
- Management of the R&D self inspection schedule for R&D functional areas
- Assist with 3rd Party Quality audits as required to support Product Development
- Drive and implement Quality Continuous Improvement Projects
- Develop and build strong business relationships with local and global quality sites where manufacturing operations and shared between sites.
- Develop Quality Key Indicators with key PD stakeholders to ensure effectiveness of quality systems within Product Development
- Attend and provide Quality oversight for Core Project Teams representing Quality for new Product Development projects as required
- Manage performance and development of R&D Quality Advisors
- Educate and inform R&D on international trends in quality and compliance in the pharmaceutical industry as they relate to biotechnology product development
- Develop and implement "Quality on the Floor" culture
Want more jobs like this?
Get Business Operations jobs in Marburg an der Lahn, Germany delivered to your inbox every week.
What you bring:
If you are interested in this challenging position, please apply via our website. For further information, please contact Mandy Jergovic or Mareike Hammerstaedt, Senior Talent Acquisition Partner.
Our Benefits
We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!