Quality Assurance Specialist

• Start: ASAP
• Duration: 12 months (with potential extension)
• Workload: 100%
• Location: Bern

In this role, you will provide quality oversight for maintenance, utilities, quality control, warehouse operations, and qualification activities in GMP projects. You will ensure compliance with cGMP, manage deviations, changes, CAPAs, and complex quality documentation, and act as QA lead during inspections and audits. The position also involves cross-functional collaboration, hosting authority inspections, and driving improvements across QA systems and processes.

• Master’s degree in a relevant discipline (or equivalent)
• 5+ years’ experience in a similar QA role within a GMP-regulated environment
• Strong expertise in cGMP, compliance, change control, deviation/CAPA management, utilities, maintenance, QC, and warehousing
• Experience leading complex investigations, audits, and cross-functional/global projects
• Skilled in technical documentation, risk assessments, and quality decision-making
• Strong communication and stakeholder management skills, with ability to coach and mentor colleagues

• High-impact QA role in a complex GMP environment
• Cross-functional and global project exposure
• Opportunity to act as subject matter expert during inspections and audits