Director, GCP Inspection Strategy & Readiness

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

Benefits offered by this job

Medical benefits

401(k) plan

Paid time off

Job summary

BeOne Medicines Ltd. seeks a Director, GCP Inspection Management - Americas, to lead inspection readiness and hosting activities for major regulatory bodies.

You will guide a team of quality professionals and coordinate with cross-functional partners to ensure proactive, unified inspection strategies. The role requires 10+ years in pharma/biotech, strong leadership, and familiarity with global regulatory requirements.

Qualifications

• 10+ years in pharmaceutical/biotech sectors.
• Experience supporting GCP inspections.
• Strong leadership and cross-functional collaboration skills.

Responsibilities

• Create and execute the GCP Inspection Strategy.
• Lead Quality professionals and consultants for IR activities.
• Coordinate with cross-functional leaders for unified IR strategy.
• Oversee timely completion of inspection commitments and CAPA closures.
• Maintain inspection forecast and lessons-learned sessions.

Skills

GCP inspection

Leadership

Regulatory affairs

Risk management

Communication skills

Education

Bachelor’s degree in Science

MS in Science

Tools

MS Office

Job description

BeOne Medicines Ltd. seeks a Director, GCP Inspection Management - Americas, to lead inspection readiness and hosting activities for major regulatory bodies.

You will guide a team of quality professionals and coordinate with cross-functional partners to ensure proactive, unified inspection strategies. The role requires 10+ years in pharma/biotech, strong leadership, and familiarity with global regulatory requirements.