Senior Director – Head of Site Quality

About the role

As the Senior Director – Head of Site Quality, you will lead the Quality function for a pharmaceutical manufacturing site in Germany. Reporting to the Site Leadership Team, you will be responsible for ensuring regulatory compliance, driving operational excellence, and supporting the commercialization of new products.

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 resolution of critical quality issues.
• Develop and execute Site Quality Plans and budgets in line with the global Quality strategy.
• Drive digital roadmap initiatives and monitor KPIs to enhance laboratory and site productivity.
• Recruit, mentor and develop a diverse, high‑performing quality team.

Required profile

• Bachelor’s degree in a scientific field.
• Minimum 10 years of management or project management experience in the pharmaceutical industry, including at least 5 years in Quality Assurance.
• Comprehensive knowledge of global cGMP, Health Authority inspections and Quality Risk Management.
• Fluency in English.

Required skills

• cGMP compliance
• FDA and EMEA inspection management
• Quality Risk Management
• Drug Product (DP) manufacturing processes
• API manufacturing and testing processes
• KPI monitoring and digital quality tools