Head of Quality (Pharmaceutical & Medical Packaging)

About the role

The Head of Quality leads the Quality Management System (QMS) across multiple production sites in pharmaceutical and medical packaging. You will ensure regulatory compliance, meet customer expectations, and drive continuous improvement.

Key responsibilities

• Own the QMS for all production sites, overseeing batch review, release, and rework approvals.
• Manage audits, inspections, complaints, deviations, CAPAs, and change controls.
• Lead supplier qualification, evaluation, and audit activities.
• Direct validation activities and maintain the Validation Master Plan.
• Review and approve quality documentation, specifications, and Quality Agreements.
• Monitor KPIs and support Management Review processes.
• Provide quality support for R&D projects.
• Train, mentor, and develop the quality team.

Required profile

• Master's degree or PhD in a scientific discipline or equivalent.
• Extensive experience in Quality Management within GMP‑regulated environments.
• Proven leadership and stakeholder management abilities.
• Fluent English and good German skills.
• Hands‑on, proactive, solution‑oriented mindset.
• Valid Category B driving licence.

Required skills

• ISO 15378
• ISO 9001
• ISO 13485 (advantage)
• Good Manufacturing Practice (GMP)
• Quality Management System (QMS) implementation
• Validation processes
• CAPA management
• Change control procedures
• Supplier qualification and audit management