As a Quality Assurance Associate, you will contribute to maintaining and strengthening the Quality Management System at the Solothurn site. In this role, you’ll support core quality activities, help coordinate routine governance processes, and assist in maintaining inspection readiness. You will collaborate with various site or global functions to ensure smooth execution of essential quality tasks. This position allows you to play an important part in sustaining a strong culture of compliance without carrying full ownership of operational responsibilities.

The holder of this position will be responsible for the following activities:
1. Audit and Inspection Support

• Coordinate and monitor audit and inspection commitments to ensure timely closure and proper documentation in line with Biogen QMS requirements.
• Organize and facilitate meetings with SMEs to review action status, gather updates, and maintain alignment on deliverables.

2. Site Meeting Governance

• Schedule and manage logistics for site governance meetings (e.g., Investigation Review Board), including agenda preparation, pre‑read collection, and documentation of decisions.
• Support governance forums related to deviations, change controls, CAPAs, and other QMS review boards to ensure consistent application of Biogen standards.
• Contribute to improving and optimizing governance meetings in line with site objectives

3. Self‑Inspection Program Execution

• Assist in planning, implementing, and tracking the Self‑Inspection Program, including scheduling activities with SMEs and ensuring timely documentation and follow‑up of observations.
• Maintain tools and trackers supporting inspection readiness and compliance monitoring.

4. QMS Administration & Operational Support

• Support QMS processes including deviations, CAPAs, change controls, training assignments, and quality risk management in accordance with Biogen procedures.
• Collaborate with cross‑functional stakeholders (QA, QC, Manufacturing, Engineering, etc.) to ensure compliance and timely completion of required actions.
• Support on KPIs reporting and monitoring

5. Documentation & Data Management

• Ensure accurate and compliant documentation of QMS activities in systems such as TrackWise, Veeva, and myCIMS.
• Maintain logs, trackers, meeting minutes, dashboards, and metrics related to QMS processes and governance activities.
• Identify opportunities to streamline QMS processes, improve documentation quality, and enhance visibility of compliance commitments.

This position requires co-operation with people at every level of the organization and from multiple functions, including engineering, automation, validation, Manufacturing personnel, SME’s on equipment and knowledge of biotechnology API production.

Good communication skills in English, verbally and written.

Self-driven and take ownership and responsibility for own assignments. Value teamwork at all levels, performs work with an open-mind and ability to value input from colleagues and peers. Able to drive discussion to solve problems with cross functional teams.

Be confident in making technical decisions. In addition, must be able to prioritize tasks, be flexible and able to keep many activities running at a time.

If you are interested in this opportunity, we look forward to receiving your CV or if you have any questions, contact Elaine Kanwar at +41 61 282 22 23.
Check out all open positions at Experis at www.experis.ch
Due to Swiss work permit restrictions, we can only consider applications from EU citizens or holders of valid working permit in Switzerland.