Senior Manager, R&D Quality Lead

Vor 2 Tagen

Marburg an der Lahn, Hessen, Deutschland CSL Vollzeit
Job Title: Senior Manager, R&D Quality

We are seeking a highly skilled and experienced Senior Manager, R&D Quality to join our team at CSL in Marburg. As a key member of our R&D Quality Management team, you will be responsible for managing the integration of R&D quality systems, policies, and procedures in line with our Global Quality Management System (QMS) for Product Development.

Key Responsibilities:
  • Develop and maintain Phase-appropriate Quality systems
  • Provide Quality oversight to the Product Development organisation for New Product Introduction, encompassing CSL and CMO manufactured and tested clinical material for Phase 1 & 2 and Phase 3 (where determined)
  • 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
Requirements:
  • 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

We encourage you to apply for this challenging position if you have the necessary skills and experience. For further information, please contact Mandy Jergovic or Mareike Hammerstaedt, Senior Talent Acquisition Partner.

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