Head of Quality

Vor 3 Tagen

Berlin, Berlin, Deutschland Discover International Vollzeit

Title:
Head of Quality / QP

Location:
Berlin, Germany

Company:

We have partnered with an established pharmaceutical services organization, who have plans to grow and are searching for a Head of Quality / Qualified Person to have autonomy over the Quality department alongside batch certification across clinical and commercial products.

Key Responsibilities

  • Act as Qualified Person with full legal responsibility for batch certification
  • Lead and develop the site Quality Assurance and Quality Control teams
  • Ensure ongoing compliance with GMP, GDP, GCP-V, and relevant German/EU legislation
  • Serve as primary quality contact for regulatory authorities and inspections
  • Maintain and improve quality systems aligned with business and regulatory expectations
  • Partner cross-functionally with operations, supply chain, and regulatory teams
  • Support clinical trial supply activities and small-batch manufacturing environments

Requirements:

  • Recognized as a Qualified Person according to §14 AMG
  • Minimum 5+ years' experience in leading Quality teams
  • Experience interacting with regulatory agencies and inspectors
  • Exposure to investigational medicinal products (IMP) is advantageous
  • Able to operate effectively in cross-functional, international environments
  • Fluency in German and English

If interested please apply to be selected for an initial screening call or reach out via LinkedIn with any questions.

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