Regional Clinical Compliance Optimization Lead

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

TheRegional Clinical Compliance(RCC)OptimizationLeadis responsible forproactivelyidentifyingsignals, trends, and systemic issues acrosscountries andEMEAregionto drive continuous improvement in clinical trialexecution andprocesses. This role plays a key part in translating operational insights into actionable improvements, partnering with Global Clinical Compliance, RBQM (Risk-Based Quality Management), and global process owners to enhance efficiency, compliance, and quality across the organization.Collaborates closely with RCC InspectionLeadand RCCLead(includingCountry RCCsas needed).

Essential Functionsof the Job:

Signal Detection & Trend Analysis

• Identifyandanalyzesignals, trends, and systemic issues across EMEA using compliance-generateddata, audit findings, inspection outcomes, and operational insights.

• Translate aggregated insights into meaningful risk patterns and improvement opportunities.

• Provide regular reporting and recommendations to stakeholders to support informed decision-making.

Process Improvement & Risk Management

• Propose and support process improvements based onidentifiedtrends and systemic issues.

• Collaborate closely with RBQM teams to integrate findings into process risk assessment and risk mitigation strategies.

• Ensure alignment of improvements with GCP requirements, company procedures, and quality standards

• Identifyareas ofadditionaltrainingand supportforpreparing and delivering such educationalsessionswithintheEMEA region

Operational Excellence & Implementation

• Support regional and country-level process improvement initiatives to enhance efficiency, compliance, and consistency.

• Act as a liaison between regional/country teams and Global Clinical Compliance and global process owners.

• Facilitate theregionalimplementation of improvementsidentifiedatglobal,localor regional levels, ensuring scalability and sustainability.

• Promote best practice sharing across countries and regions.

Stakeholder Collaboration & Influence

• Partner cross-functionallywith Clinical Operations, Quality Assurance, RBQM, and Global Compliance teams.

• Influence stakeholders at multiple levels to drivethe adoptionof process enhancements.

• Support change management activities related to new or updated processes.

Supervisory Responsibilities:Notapplicable

Education Required:

• Bachelor’s degree (BS/BA or equivalent) or higher in a scientific,medicalor healthcarediscipline*with10+years in clinical research, clinical operations,plusminimum4years *experience in a GCP compliance or equivalent role**(i.e. quality) is preferred

*Exceptionsmay be made for candidates with equivalentappropriate ClinicalOperations experience.

**Experience in data analytics, metrics and KPI management is preferred

Computer Skills:PC literacyrequired;MS Officeskills (Outlook, Word, Excel, PowerPoint)

Other Qualifications:

• 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

• Experiencein oncologyglobal trials is preferred.

Travel:upto10%travel

Salary Range Switzerland: 156,200.00 CHF - 195,200.00 CHF

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity