Senior Manager, R&D Quality (m/f/d) – R-229349

Detailansicht des Stellenangebots Stellendetails zu: Senior Manager, R&D Quality (m/f/d) - R-229349 Senior Manager, R&D Quality (m/f/d) - R-229349KopfbereichArbeitPharmazeut/inSenior Manager, R&D Quality (m/f/d) - R-229349CSL Behring GmbHVollzeitMarburgab 20.05.2024unbefristetGesternStellenbeschreibung

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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Über CSL Behring
CSL Behring ist ein weltweit führendes Unternehmen, das hochwertige Therapeutika für Menschen mit seltenen und ernsten Krankheiten entwickelt und vertreibt. Mit unseren Medikamenten für die Therapiegebiete Immunologie, Hämatologie, Herz-Kreislauf und Stoffwechsel, Atemwegserkrankungen und Transplantationsmedizin halten wir unser Versprechen, die Lebensqualität von Patienten in mehr als 100 Ländern zu verbessern. Erfahren Sie mehr über CSL Behring.
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