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    vor 3 Wochen


    Marburg an der Lahn, Hessen, Deutschland CSL Vollzeit

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    vor 4 Wochen


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Lead Manager, R&D Quality Assurance

vor 3 Monaten


Marburg an der Lahn, Hessen, Deutschland CSL Vollzeit

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

Position Overview:

The Senior Manager of R&D Quality is responsible for overseeing the integration of quality systems, policies, and procedures in alignment with the Global Quality Management System (QMS) for Product Development.

Key Responsibilities:

  • Oversee the development and maintenance of quality systems appropriate for each phase of product development.
  • Provide quality oversight for the Product Development organization, particularly for New Product Introductions.
  • Act as the primary representative for R&D Quality in site quality management discussions.
  • Manage the R&D quality unit, focusing on change control, batch technical release, deviation management, and risk management activities.
  • Lead and implement continuous improvement initiatives in quality processes.
  • Establish Quality Key Performance Indicators in collaboration with key stakeholders in Product Development.
  • Educate and update R&D teams on global trends in quality and compliance standards.

Qualifications:

  • Bachelor's or Master's degree in a relevant field.
  • Proven experience in pharmaceutical manufacturing.
  • Strong understanding of GxP and both domestic and international regulations.
  • Experience in the application of Quality Systems.
  • Previous experience in personnel management.
  • Fluency in English; proficiency in German is advantageous.