Miltenyi Biotec

Analytical Project Lead - Quality Control (m|f|d)

Stellenbeschreibung:

Overview

In this role, you lead international quality control activities for cell therapy products within a matrix organization. You partner with cross-functional teams to manage QC project timelines, technology transfer, and regulatory submissions across regions. You ensure global comparability of analytical testing and drive risk management for successful product roll-out. You contribute to shaping QC strategy and mentor colleagues as you grow into a leadership role.

Leistungen / Benefits
  • Flexible and remote work
  • Diversity: international teams
  • Room for creativity
  • Health & Sport benefits
  • Miltenyi University training
  • inclusive work environment
Verantwortungsbereiche
  • Serve as primary contact and analytical project lead for international QC activities related to cell therapy products
  • Oversee QC project timelines, deliverables, and risk management for international roll-out
  • Lead international transfer and implementation of QC testing strategies across Miltenyi sites and point-of-care centers
  • Author and review critical QC documents (validation protocols, reports, specifications, transfer packages)
  • Provide QC expertise for regulatory submissions beyond Europe and the US
  • Ensure global comparability and regulatory alignment of analytical testing across regions
  • Coordinate QC activities with R&D, Manufacturing, QA, Regulatory Affairs, and other functions
  • Support evolution of QC leadership and strategic initiatives within the department
Zentrale Anforderungen
  • Master's degree in a life sciences field with GMP-regulated QC or analytical development experience
  • Several years of cross-functional project leadership in biotech/pharma
  • Strong communication and stakeholder management across functions
  • Structured, analytical, solution-oriented mindset for complex challenges
  • Fluency in German and English; additional languages are a plus
  • Willingness to travel internationally for technology transfer and collaboration
  • strong communication
  • stakeholder management
  • collaboration
  • GMP-regulated Quality Control
  • analytical development
  • regulatory submissions support
NOTE / HINWEIS:
EnglishEN: Please refer to Fuchsjobs for the source of your application
DeutschDE: Bitte erwähne Fuchsjobs, als Quelle Deiner Bewerbung

Stelleninformationen

  • Veröffentlichungsdatum:

    14 Sep 2026
  • Standort:

    Bergisch Gladbach

    Einsatzort:

    Lüdinghausen, Germany
  • Typ:

    Vollzeit
  • Arbeitsmodell:

    Vor Ort
  • Kategorie:

  • Erfahrung:

    2+ years
  • Arbeitsverhältnis:

    Angestellt

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