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 ResponsibilitiesNotapplicable
Education Required:
Bachelor’s degree (BS/BA or equivalent) or higher in a scientific,medicalor healthcare discipline*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:up to10%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.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
Effective March 17, 2025, The U.S. subsidiary of BeiGene, Ltd. has changed its name to BeOne Medicines USA, Inc. This change comes ahead of our anticipated global rebranding to BeOne Medicines Ltd. and redomiciliation to Switzerland, pending shareholder approval. The new name reflects our commitment to develop innovative medicines and partner with the global community to help as many patients with cancer as possible.
To learn more about BeOne Medicines, please follow our new LinkedIn profile @BeOne Medicines.
