The Site RP is a key member of the Quality Leadership Team responsible for ensuring compliance with Swissmedic Technical Interpretation I-SMI.TI.17
Job Summary
The Site RP is a key member of the Quality Leadership Team responsible for ensuring compliance with Swissmedic Technical Interpretation I-SMI.TI.17.
The role involves leading audits, mentoring auditors, managing deviations, change controls, and providing quality oversight across multiple site operations.
The Werthenstein BioPharma site in Schachen conducts cutting-edge research and supplies clinical trial products globally, emphasizing security and safety.
Matching Summary
The Site RP is a key member of the Quality Leadership Team responsible for ensuring compliance with Swissmedic Technical Interpretation I-SMI.TI.17.
Skills & Requirements
Must-have
Batch Record review and certification
Quality Management System oversight
Audit program leadership and execution
Deviation and CAPA management
Regulatory inspection support
Cross-functional collaboration and communication
Quality enterprise systems experience
Nice-to-have
Mentoring and coaching auditors
Project management skills
Change and process initiative leadership
Risk communication
Continuous improvement facilitation
Strong influencing and negotiation skills
Key Requirements
Bachelor’s degree in Life Science
10+ years in Quality Role in Sterile/Low Bioburden Biological Drug Substance Manufacturing
Eligible as Responsible Person per I-SMI.TI.17
Previous experience as Responsible Person
Experience with LIMS, SAP-Quality, MES, Veeva Q-Docs