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Director of Quality Assurance – Pharmaceuticals (Germany)

Barrington James · Berlin

Nuevo
Senior 🇬🇧 English
EU GMP GDP CAPA Change control

Descripcion del puesto

About the role

We are seeking an experienced Director of Quality Assurance to lead the QA function within a GMP‑regulated pharmaceutical environment in Germany. The role will shape QA strategy, ensure regulatory compliance, and drive continuous improvement across manufacturing and supply chain operations.

Key responsibilities

  • Define and execute QA strategy and operational plans for manufacturing and supply chain.
  • Maintain compliance with EU GMP, GDP and global regulatory standards.
  • Oversee Quality Management System activities, including deviations, CAPAs, change controls and internal audits.
  • Lead regulatory inspections and ensure inspection readiness.
  • Collaborate with Manufacturing, Regulatory Affairs and Operations teams to align quality objectives.
  • Develop, mentor and manage high‑performing QA teams.

Required profile

  • Significant leadership experience in pharmaceutical quality assurance.
  • Strong knowledge of EU GMP and related regulatory requirements.
  • Proven track record managing inspections and quality systems.
  • Excellent leadership and stakeholder management abilities.
  • Fluent English; German language skills are desirable.
  • QP eligibility is advantageous.

Required skills

  • EU Good Manufacturing Practice (GMP)
  • Good Distribution Practice (GDP)
  • Quality Management System (QMS) administration
  • Deviation handling and Corrective & Preventive Actions (CAPA)
  • Change control processes
  • Audit planning and execution
  • Regulatory inspection management

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Publicado hace 3 horas

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Barrington James

Berlin