Regional Clinical Compliance Optimization Lead
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Job Description
Clinical compliance lead analyzing EMEA trial signals and risks for BeOne, a cancer-medicine company. Driving GCP process improvements, RBQM collaboration, and regional implementation.
Responsibilities:
- Proactively identify and analyze signals, trends, and systemic issues across EMEA using compliance-generated data, audit findings, inspection outcomes, and operational insights
- Translate aggregated insights into risk patterns and improvement opportunities
- Provide regular reporting and recommendations to stakeholders
- Propose and support process improvements based on identified trends and systemic issues
- Collaborate with RBQM teams to integrate findings into process risk assessments and mitigation strategies
- Ensure alignment of improvements with GCP requirements, company procedures, and quality standards
- Identify additional training needs and support preparation and delivery of educational sessions within EMEA
- Support regional and country-level process improvement initiatives
- Liaise between regional/country teams, Global Clinical Compliance, and global process owners
- Facilitate regional implementation of global, local, or regional improvements
- Promote best-practice sharing across countries and regions
- Partner with Clinical Operations, Quality Assurance, RBQM, and Global Compliance teams
- Influence stakeholders to adopt process enhancements
- Support change-management activities related to new or updated processes
Requirements:
- Bachelor’s degree (BS/BA or equivalent) or higher in a scientific, medical or healthcare discipline
- 10+ years in clinical research or clinical operations
- Minimum 4 years’ experience in a GCP compliance or equivalent quality role is preferred
- Exceptions may be made for candidates with equivalent appropriate Clinical Operations experience
- PC literacy required
- MS Office skills (Outlook, Word, Excel, PowerPoint)
- Experience with RBQM principles, risk identification, and data-driven decision-making
- Experience in process improvement, operational excellence, or quality initiatives
- Certification in quality management, clinical research, or process improvement methodologies (e.g., Lean Six Sigma) will be a plus
- Experience supporting or implementing global process changes
- Experience in oncology global trials is preferred
Benefits:
- Equal opportunity employment
- Up to 10% travel
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