• 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

• What you bring:

• Bachelor degree or Master degree
• Experience in pharmaceutical manufacturing is highly desirable
• Sound knowledge of GxP, domestic & international regulation, processes & registered condition
• Experience and knowledge in the application of Quality Systems
• Previous experience with personnel management
• English language fluency, German language is a plus

• 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.

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