Director, GCP Inspections Strategy – Americas

BeiGene, Ltd.; United States; Remote; USD 172,000 - 232,000; Full time

Job summary

BeOne Medicines Ltd. is seeking a Director, GCP Inspection Management - Americas to lead inspection readiness, hosting and coordination of GCP inspections by health authorities.

You will develop and execute a risk-based GCP inspection strategy and manage cross-functional collaboration to ensure timely inspection outcomes. The role includes leading quality professionals, coordinating with inspectorates, maintaining inspection plans, and driving continuous improvement across quality systems.

Qualifications

• 10+ years in pharma/biotech with 5+ years supporting GCPs and inspections.
• Experience leading quality teams and hosting inspections
• Strong regulatory knowledge across FDA/EMA/other authorities

Responsibilities

• Create and execute the GCP Inspection Strategy.
• Lead a team of Quality professionals to carry out GCP IR activities.
• Collaborate with cross‑functional leaders to unify Inspection Readiness strategy.
• Oversee timely fulfillment of inspection commitments and responses to findings.
• Maintain inspection forecast and outcome tracker.
• Provide lessons learned sessions and drive process improvements.
• Chair the IOC meetings and oversee SOP updates.
• Manage training and qualifications of Quality staff.
• Support other inspection types (GLP/GxP) as needed.

Skills

GCP inspections

Regulatory knowledge

Team leadership

Cross‑functional collaboration

Project management

Education

Bachelor's degree in Science

Tools

MS Office

Job description

BeOne Medicines Ltd. is seeking a Director, GCP Inspection Management - Americas to lead inspection readiness, hosting and coordination of GCP inspections by health authorities.

You will develop and execute a risk-based GCP inspection strategy and manage cross-functional collaboration to ensure timely inspection outcomes. The role includes leading quality professionals, coordinating with inspectorates, maintaining inspection plans, and driving continuous improvement across quality systems.