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Head of Quality Control

Stellenbeschreibung:

Associate Director - Quality & Technical Operations Europe

Head of Quality Control & Analytical Development

A pioneering biopharmaceutical company developing next-generation therapeutics is seeking a Head of QC & Analytical Development to take strategic and operational ownership of all analytical and quality control activities across their German manufacturing site.

The Role

  • Lead and develop multidisciplinary QC and Analytical teams (Analytical Development, Raw Material, In-Process, Release, and Stability testing)
  • Oversee method development, qualification, validation, and transfer of analytical methods supporting both Drug Substance and Drug Product manufacturing
  • Ensure full GMP compliance for all QC operations, including data integrity, investigations, and regulatory inspections
  • Act as the key technical authority for analytical strategy, working closely with QA, Manufacturing, Regulatory Affairs, and R&D
  • Drive continuous improvement initiatives and analytical lifecycle management to enhance efficiency and scientific robustness
  • Represent QC in cross-functional CMC and tech transfer projects, both internally and with external partners or CMOs

Your Background

  • Degree (PhD, MSc, or equivalent) in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field
  • 10+ years’ experience in QC and/or Analytical Development within biologics, radiopharmaceuticals, or advanced therapies
  • Proven leadership experience managing QC laboratories in a GMP-regulated environment
  • Strong knowledge of analytical techniques (HPLC, GC, CE, spectroscopy, bioassays) and regulatory guidelines (ICH, EMA, FDA)
  • Experience in tech transfer, method validation, and regulatory submissions highly desirable
  • Fluent in English & German language skills advantageous

Seniority level

Director

Employment type

Full-time

Job function

Quality Assurance

Industries

Pharmaceutical Manufacturing and Biotechnology Research

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EnglishEN: Please refer to Fuchsjobs for the source of your application
DeutschDE: Bitte erwähne Fuchsjobs, als Quelle Deiner Bewerbung

Stelleninformationen

  • Typ:

    Vollzeit
  • Arbeitsmodell:

    Vor Ort
  • Kategorie:

  • Erfahrung:

    2+ years
  • Arbeitsverhältnis:

    Angestellt
  • Veröffentlichungsdatum:

    04 Nov 2025
  • Standort:

    Marburg

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