Regional Clinical Compliance Optimization Lead

BeOne Medicines

. Proactively identify and analyze signals, trends, and systemic issues across EMEA using compliance-generated data, audit findings, inspection outcomes, and operational insights .

Posted 11/9/2026full-timeRemote • NetherlandsSenior💰 €107,200 - €134,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in GCP compliance, clinical research, and process improvement, with a strong focus on data-driven decision-making and stakeholder collaboration. Proven ability to identify trends, propose enhancements, and facilitate training within clinical operations.

Highest-signal resume keywords

GCP ComplianceClinical ResearchProcess ImprovementData-Driven Decision-MakingRisk Identification

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical OperationsOperational ExcellenceQuality InitiativesRisk AssessmentData AnalysisProcess EnhancementTrend AnalysisReportingTraining DeliveryChange Management

Soft Skills

Stakeholder InfluenceCollaborationCommunicationProblem-SolvingBest-Practice Sharing

Tools & Technologies

MS OfficePC Literacy

Certifications & Qualifications

Quality Management CertificationClinical Research CertificationLean Six Sigma Certification

Industry Keywords

Oncology Global TrialsRBQM PrinciplesEMEA ComplianceAudit FindingsInspection Outcomes

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

Equal opportunity employment
Up to 10% travel