Senior Manager Quality Operations, Delegate RP/FvP
Core
Delegate Responsible Person (RP/FvP) ensuring GMP/GDP compliance for manufacturing and trading operations of medicinal products.
Role type
Senior Manager Quality Operations (Delegate RP/FvP)
Builds
Medicinal products manufactured and traded in compliance with Swiss and international guidelines
Domain
Pharmaceutical industry, Quality Management, GMP/GDP
Required skills
GMP/GDP compliance, Quality Management System maintenance, batch release, supplier qualification, risk assessment, CAPA management, regulatory reporting, SAP data management, quality agreements, recall coordination, self-inspection leadership
Preferred skills
Previous Responsible Person (FvP) experience, French and/or German language fluency, Contract Manufacturing Organization (CMO) visit experience
Technologies
SAP, Veeva, electronic Document Management Systems
Responsibilities
Maintain and improve Quality Management System, issue directives within area of responsibility, ensure external manufacturing/trading compliance, perform supplier/customer bona fide checks, conduct supplier qualification, support recall operations, lead self-inspections, author/review SOPs, manage customer complaints, apply Quality Risk Management, raise/manage deviations, collate KPIs, support Health Authority inspections, participate in GMP training, lead multi-site quality projects, perform plant visits at CMOs, lead qualification/validation activities, perform technical GMP release, approve product redeployments, author quality agreements, issue Notifications to Management, maintain quality master data, report quality issues to Swissmedic, manage 'Ship on Test' forms
Seniority
Senior Manager, hands-on IC with leadership responsibilities