Senior Director – Head of Site Quality

About the role

As the Senior Director and Head of Site Quality, you will lead the Quality function for a pharmaceutical manufacturing site in Germany. This strategic position oversees Quality Assurance, Quality Control, and regulatory compliance, ensuring the site delivers safe, effective products while supporting new product commercialization.

Key responsibilities

• Direct all Quality Management and Compliance activities, aligning with global Quality Systems and regulatory requirements.
• Lead health‑authority inspection readiness (FDA, EMEA) and manage escalation of critical quality or technical issues.
• Develop and execute Site Quality Plans and budgets, supporting the global Quality strategy.
• Drive operational excellence and digital roadmap initiatives to improve laboratory and site productivity.
• Recruit, mentor, and develop a diverse, high‑performing quality team.

Required profile

• Bachelor’s degree in a scientific discipline.
• Minimum 10 years of management or project‑management experience in the pharmaceutical industry, including at least 5 years in Quality Assurance.
• Proven ability to lead complex quality functions and navigate organizational transformations.
• Fluency in English.

Required skills

• cGMP knowledge
• FDA/EMEA inspection management
• Quality Risk Management
• Drug Product (DP) manufacturing processes
• API manufacturing and testing processes