Overview
In this role you lead GCP inspection readiness for cross-functional clinical study teams, ensuring global regulatory compliance. You manage end-to-end planning, mock and actual Health Authority inspections, and risk-based readiness strategies to support BeOne’s cancer-focused R&D. You develop SOPs and strengthen QA systems while driving continuous improvement and timely responses. This position offers impact on global regulatory readiness and operational excellence in our research programs.
Verantwortungsbereiche
- Lead GCP inspection readiness activities and serve as inspection lead for regulatory Health Authority inspections (FDA, MHRA, EMA, CFDI, MFDS, PMDA, TGA, TFDA)
- Collaborate with cross-functional clinical study teams to implement an integrated readiness strategy
- Oversee end-to-end inspection activities, develop SME-driven inspection storyboards, and coordinate mock and live inspections
- Coordinate and assign inspection requests to SMEs, guiding accurate and timely responses during regulatory visits
- Create or revise SOPs and tools for inspection readiness and management
- Maintain QA systems (investigations, SQEs, Deviations, CAPAs)
- Manage post-inspection actions, root-cause analysis, and timely closure of corrective actions
- Maintain a central repository of global inspection status and updates
- Support Site Inspection Preparation Visits (SIPV) at investigative sites
- Lead post-inspection lessons learned sessions to drive sustainable improvements
- Define strategic direction to enhance quality systems, inspection readiness, and operational excellence
- Mentor and develop team members and cross-functional partners
- Demonstrate deep understanding of global regulatory requirements governing clinical trials across regions
- Travel up to 35% as needed
Zentrale Anforderungen
- +7 years of experience in GCP-related Quality Assurance in pharma/biotech
- Strong understanding of international GCP requirements and standards in pharma/biotech/medical devices
- Excellent English language skills; additional languages depending on location
- Excellent verbal and written communication; ability to collaborate in a dynamic environment
- Experience leading cross-functional teams and inspection readiness initiatives
- Willingness to travel internationally up to 35%
- collaboration
- leadership
- strong communication
- GCP inspection readiness
- Health Authority inspections (FDA, MHRA, EMA, etc.)
- QA systems (investigations, SQEs, Deviations, CAPAs)
Senior Manager, GCP Inspection Lead in Basel Arbeitgeber: BeiGene
BeOne ist ein hervorragender Arbeitgeber, der eine dynamische und unterstützende Arbeitsumgebung bietet, in der Mitarbeiter ihre Fähigkeiten weiterentwickeln und an bedeutenden Projekten zur Bekämpfung von Krebs mitwirken können. Mit einem klaren Fokus auf kontinuierliches Lernen und Entwicklung fördert BeOne eine Kultur der Zusammenarbeit und Innovation, während die strategische Lage in Deutschland den Zugang zu einem breiten Netzwerk von Fachleuten und Ressourcen ermöglicht. Die Möglichkeit, an der Gestaltung von Schulungsprogrammen für neue Produkte und Marktstrategien mitzuwirken, macht diese Position besonders attraktiv für engagierte Fachkräfte.
