Beschreibung

As a Quality Assurance Manager, you will play a crucial role in ensuring product safety and compliance by managing quality systems, collaborating with teams, and addressing supplier and customer concerns. Your day-to-day responsibilities will involve fostering a culture of quality and continuously improving processes to meet regulatory standards.

Anforderungen

• •Several years of experience in quality management
• •Experience with quality assurance techniques and tools
• •Experience in managing supplier relationships and conducting audits
• •Excellent communication skills
• •Ability to perform in a dynamic environment
• •Bachelor’s and master’s degree in Pharmacy or related field
• •Fulfilment of requirement under § 14 Abs. 1 Nr. 4 of the German Medicines Act (AMG) is a plus
• •Fluency in English
• •Very good knowledge of German

Aufgaben

• •Implement and maintain quality management systems
• •Support the Head of Quality in managing quality assurance
• •Collaborate with teams to ensure product safety and efficacy
• •Foster a culture of quality in decision-making processes
• •Execute supplier qualification processes and maintain a register
• •Manage supplier relationships and conduct performance reviews
• •Execute product qualification processes per company procedures
• •Collaborate with Product Development and Procurement teams
• •Manage the complaints process and address quality-related issues
• •Analyze complaint data to identify trends and improvements
• •Organize and document quality processes for GMP, GDP, and ISO 13485
• •Ensure compliance with legal requirements across all business areas
• •Continuously improve processes and maintain inspection readiness
• •Provide regulatory support to Business Development and product managers
• •Prepare and implement employee training on regulations
• •Evaluate new regulatory impacts on business processes
• •Maintain the Quality network and share best practices
• •Deputize the Head of Quality during absences

Tools & Technologien

Benefits