The Biologics drug substance manufacturing facility at Schachen is a premier, state-of-the-art facility that enables and advances our best work
Job Summary
The Biologics drug substance manufacturing facility at Schachen is a premier, state-of-the-art facility that enables and advances our best work.
The Site RP (Responsible Person) is a key member of the Quality Leadership Team, having responsibility to ensure that the site meets the expectations as laid out in the Swissmedic Technical Interpretation (I-SMI.TI.17).
Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities.
Matching Summary
The Biologics drug substance manufacturing facility at Schachen is a premier, state-of-the-art facility that enables and advances our best work.
Skills & Requirements
Must-have
Responsible Person for batch release
Swissmedic Technical Interpretation I-SMI.TI.17
Low bioburden drug substance manufacturing
Clinical supply packaging and distribution
Quality Management System oversight
Internal and external audit leadership
Nice-to-have
Cross-functional teamwork and collaboration
Mentoring and coaching auditors
Continuous improvement initiatives
Risk communication to management
Permanent inspection readiness
Key Requirements
Bachelor’s degree or higher in Life Science
10+ Years Experience in Quality Role
Eligible as Responsible Person per I-SMI.TI.17
Experience with Quality Enterprise Systems (LIMS, SAP-Q, MES, Veeva)