Global GCP Inspection Lead, Senior Manager

BeOne Medicines Ltd.; Basel; On-site; CHF 142,000 - 177,000; Full time

Job summary

BeOne Medicines Ltd. is seeking an experienced Senior Manager, Inspection Management to lead GCP inspection readiness across global clinical teams.

You will coordinate inspection planning, logistics, and responses to Health Authority inquiries, ensuring compliance with applicable guidelines and internal standards. The role requires strong cross-functional collaboration, oversight of SOPs and QA systems, and the ability to mentor staff while driving continuous process improvements and timely

Qualifications

• 7+ years in GCP-related QA in pharma/biotech.
• Strong knowledge of international GCP requirements.
• Excellent English, additional languages optional.
• Excellent verbal and written communication.
• Ability to collaborate in a dynamic environment.

Responsibilities

• Lead GCP inspection readiness activities and serve as 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 and create inspection storyboards.
• Coordinate inspection responses with SMEs and ensure timely, accurate resolutions.
• Create and revise SOPs and tools for inspection readiness and management.
• Maintain QA systems including investigations, SQEs, Deviations, and CAPAs.
• Oversee SIPV preparation and post-inspection lessons learned sessions.
• Support strategic direction to enhance quality systems and operational excellence.

Skills

GCP inspection readiness

Regulatory inspections

Cross-functional collaboration

Leadership skills

English proficiency

Problem solving

Tools

MS Office

Job description

BeOne Medicines Ltd. is seeking an experienced Senior Manager, Inspection Management to lead GCP inspection readiness across global clinical teams.

You will coordinate inspection planning, logistics, and responses to Health Authority inquiries, ensuring compliance with applicable guidelines and internal standards. The role requires strong cross-functional collaboration, oversight of SOPs and QA systems, and the ability to mentor staff while driving continuous process improvements and timely