Senior Manager QA, Fill & Finishing, Engineering & Operations

Summary

The Senior manager will be responsible for Quality Assurance oversight of Engineering and Operations fill & finishing related activities at Incyte's manufacturing facility in Yverdon-les-Bains, Switzerland.

The Senior manager will ensure QA deliverables related to classified rooms and utilities qualification, filling line validation, and overall operational GMP readiness in accordance with cGMP regulations, company policies, and regulatory requirements, including Eudralex GMP Annex 1.

The Senior manager will work closely with production, engineering, and manufacturing science teams, ensuring compliance and operational excellence.

Duties And Responsibilities

Project phase – Design, Qualification & Commissioning

• Act as the QA lead in engineering projects involving aseptic filling line, isolator and cleanroom infrastructure.
• Ensure early QA involvement in design and risk assessments, embedding GMP, Annex 1...