Quality Engineering Compliance Manager

General Information

• Start Date: Immediate / June 2026
• Location: Stein (hybrid)
• Project Environment: Greenfield CAPEX Project / New Downstream Center

Your Responsibilities

• Review and approval of URS, Quality Risk Assessments, and Design Qualification documentation
• Ensure compliance oversight for GMP-relevant systems and equipment such as: HPLCs, Freeze Dryers, Spray Dryers, Cleanrooms Grade C & D, Utilities and Process Gases
• Provide quality support for URS documentation, design concepts, and engineering deliverables
• Act as Quality Reviewer/Approver for Deviations and Change Controls
• Collaborate closely with Engineering, User Representation, Planners, and Operational Departments
• Support compliance oversight activities in C&Q and CSV
• Assist with the qualification of suppliers and service providers
• Support audits, supplier assessments, and other quality-relevant activities
• Contribute to the establishment and further development of the Quality Organization during the project phase

Your Profile

• Minimum 5 years of experience in Quality Engineering within GMP-regulated pharmaceutical environments
• Solid experience in compliance oversight of C&Q and CSV activities within CAPEX projects
• Experience with digital validation systems such as Kneat
• Good knowledge of relevant GMP regulations and industry standards (EU GMP, FDA, ICH, ISPE, GAMP)
• Structured, proactive, and solution-oriented approach to work
• Strong communication and stakeholder management skills
• Fluent German and English

Why this project?

This role offers the opportunity to be part of a strategically important Greenfield project within the Swiss pharmaceutical industry. You will support the establishment of a new production environment and work together with experienced project and quality experts in a visible and dynamic CAPEX environment.