1. For our R&D Quality Management in Marburg we are currently looking for a:
2. 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:
3. Manage integration of R&D quality systems, policies and procedures in line with CSL Global Quality Management System (QMS) for Product Development
4. Develop and maintain Phase appropriate Quality systems
5. 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)
6. Primary representative for R&D Quality in site quality management forums and discussions
7. 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
8. Provide QA disposition on R&D deviations/CAPAs and Investigations for R&D clinical materials
9. Accountable for the QA team for the technical review and disposition of non- clinical toxicological material and clinical material
10. Management of the R&D self inspection schedule for R&D functional areas
11. Assist with 3rd Party Quality audits as required to support Product Development
12. Drive and implement Quality Continuous Improvement Projects
13. Develop and build strong business relationships with local and global quality sites where manufacturing operations and shared between sites.
14. Develop Quality Key Indicators with key PD stakeholders to ensure effectiveness of quality systems within Product Development
15. Attend and provide Quality oversight for Core Project Teams representing Quality for new Product Development projects as required
16. Manage performance and development of R&D Quality Advisors
17. Educate and inform R&D on international trends in quality and compliance in the pharmaceutical industry as they relate to biotechnology product development
18. Develop and implement “Quality on the Floor” culture
19.
What you bring:
20. Bachelor degree or Master degree
21. Experience in pharmaceutical manufacturing is highly desirable
22. Sound knowledge of GxP, domestic & international regulation, processes & registered condition
23. Experience and knowledge in the application of Quality Systems
24. Previous experience with personnel management
25. English language fluency, German language is a plus
26. 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.