About the Role
As Head of Plant Quality -Syringe Plant, you will lead and develop the plant’s quality organization, ensuring the highest standards of product quality, regulatory compliance, and operational performance.
Your key responsibilities include:
Leading and developing the plant quality organization in compliance with operational, regulatory, and GMP requirements
Managing and developing the quality team, including performance management, coaching, and personnel development
Ensuring effective induction, qualification, and continuous development of employees through subordinate managers
Strategic long-term planning regarding personnel, equipment, and processes (e.g., OPSP, CAPEX)
Acting as the main contact for customers regarding quality matters
Collaborating closely with plant management, production, HR, customers, and sister plants
Planning and implementing investments for optimization and plant expansion
Driving continuous improvement initiatives and coordinating GMS activities
Managing the quality cost center and KPIs, including reporting and performance monitoring
Leading quality-related projects within the plant environment
Conducting management reviews and implementing improvement measures
Monitoring and supporting internal and external audits
Planning and conducting production rounds (GMP, 5S)
Acting as the Plant Quality Management Representative
Qualifications
Minimum 5 years of experience in Quality Management within a manufacturing environment
Experience in injection molding, medical devices, or pharmaceutical packaging is highly desirable
Bachelor’s degree or higher in Engineering, Science, or related field
Six Sigma certification (Green/Black Belt) is an advantage
Strong leadership experience in building, qualifying, and developing teams
Experience with MES, SAP, and MS Office
Knowledge of cleanroom environments is a plus
Excellent communication skills in complex and international environments
Macedonian and English fluency required; German is an advantage
Strong leadership qualities with integrity, transparency, and appreciation for people
High level of intercultural awareness and ability to work in a global environment
Proactive, flexible, and resilient personality with a confident demeanour