Global GCP Inspection Lead - Senior Manager

BeiGene, Ltd.; Basel; Vor Ort; CHF 142.000 - 177.000; Vollzeit

Zusammenfassung

BeOne is seeking a Senior Manager, Inspection Management in Switzerland to lead GCP inspection readiness across clinical study teams. You will coordinate inspection planning, responses, and post-inspection actions while driving improvements in QA systems.

The role requires strong regulatory knowledge, leadership, and ability to manage multiple inspections globally, with up to 35% travel.

Qualifikationen

• 7+ years of experience in GCP-related Quality Assurance in pharma/biotech.
• High understanding of international GCP requirements and standards.

Aufgaben

• Lead and oversee GCP inspection readiness activities and inspection lead for regulatory Health Authority inspections.
• Collaborate with cross-functional clinical study teams to develop an integrated inspection readiness strategy.
• Manage end-to-end inspection readiness activities, including development of inspection storyboards and mock inspections.

Kenntnisse

GCP QA leadership

Inspection readiness

Cross-functional collaboration

Regulatory knowledge

Leadership

Tools

SOP development

CAPA tracking

Jobbeschreibung

BeOne is seeking a Senior Manager, Inspection Management in Switzerland to lead GCP inspection readiness across clinical study teams. You will coordinate inspection planning, responses, and post-inspection actions while driving improvements in QA systems.

The role requires strong regulatory knowledge, leadership, and ability to manage multiple inspections globally, with up to 35% travel.