Head of Quality

Head of Quality (
pharmaceutical packaging/ medical packaging
) Overview

The Head of Quality is responsible for maintaining and continuously improving the Quality Management System (QMS) across multiple production sites, ensuring compliance with regulatory requirements, customer expectations and internal standards.

• Overall ownership of the QMS across all production sites
• Batch review and release, including rework/reprocessing approval
• Management of audits, inspections, complaints, deviations, CAPAs, and change controls
• Supplier qualification, evaluation, and audits
• Ownership of validation activities and the Validation Master Plan
• Review and approval of quality documentation, specifications, and Quality Agreements
• KPI monitoring and Management Review support
• Quality support for R&D projects
• Training, mentoring, and development of employees

• Master's degree or PhD in a scientific discipline or equivalent
• Strong experience in Quality Management within GMP-regulated environments
• Experience with ISO 15378 and ISO 9001 (ISO 13485 is an advantage)
• Background in pharmaceutical or medical device packaging
• Fluent English and good German skills
• Proven leadership experience and strong stakeholder management skills
• Hands-on, proactive, and solution-oriented mindset
• Driving license (Category
  
  B)

An experienced Quality leader with a strong background in GMP, audits, supplier quality, validation, and quality systems, ideally gained within pharmaceutical packaging or regulated manufacturing environments.