Quality Engineering Compliance Manager

About

As part of the growth of our Swiss Consulting team, we need reinforcement from an experienced Quality Engineering Compliance Manager for an exciting pharmaceutical greenfield project (Canton Aargau).

The role is part of a new Downstream Manufacturing Center for chemically synthesized peptides within a large CAPEX expansion project. You will accompany the setup of a GMP-regulated production environment from an early project phase and work closely with various specialist areas and project teams.

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
• Ensuring compliance oversight for GMP-relevant systems and equipment such as:
  • HPLCs
  • Freeze Dryers
  • Spray Dryers
  • Cleanrooms Grade C & D
  • Utilities and Process Gases
• Quality support for URS documentation, design concepts, and engineering deliverables
• Acting as Quality Reviewer/Approver for Deviations and Change Controls
• Close collaboration with Engineering, User Representation, Planners, and Operational Departments
• Supporting compliance oversight activities in C&Q and CSV
• Participating in the qualification of suppliers and service providers
• Assisting with audits, supplier assessments, and other quality-relevant activities
• Contributing to the establishment and further development of the Quality Organization during the project phase

Your Profile

• At least 5 years of experience in Quality Engineering within GMP-regulated pharmaceutical environments
• In-depth 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 skills

Why this Project?

This role offers the opportunity to become 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.