Head of Quality Assurance

About the role

The Head of Quality Assurance will lead a team of approximately six employees and oversee the further development of the Quality Management System (QMS) to ensure regulatory compliance and operational efficiency. This role involves managing core QMS processes, supplier qualification, and regulatory documentation while ensuring adherence to GMP/GDP and MedCanG requirements. The position reports directly to the management board and requires close collaboration with the Qualified Person and various internal departments.

Responsibilities

• Lead and manage the QA team of approximately six employees
• Develop and maintain the Quality Management System (QMS) regarding compliance and efficiency
• Ensure adherence to GMP, GDP, and MedCanG requirements
• Manage core QMS processes including CAPA, risk management, change control, and audits
• Oversee supplier and service provider qualification and quality agreements
• Coordinate regulatory documentation and computerized system validation
• Prepare and support authority inspections and customer audits

Required skills

• Quality Assurance
• GMP
• GDP
• QMS
• CAPA
• Risk Management
• Change Control
• Regulatory Compliance
• German
• English

Nice to have

• MedCanG
• BtMG
• AmRadV

Qualifications

• Degree in natural sciences or engineering (e.g., Pharmacy, Chemistry, Biology, Biotechnology, Process Engineering)
• Equivalent long-term professional experience in relevant fields

Benefits

• Flex Office model
• Mobile working
• 30 days of vacation
• Urban Sports Club membership
• Subsidized lunch
• Childcare subsidy
• Company pension scheme
• Professional development opportunities
• Modern equipment

About the Company

Semdor Pharma Group GmbH is a company operating in a dynamic environment with flat hierarchies and an open corporate culture.