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. The Senior Manager R&D Quality Analytics & Portfolio Insights is a specialized R&D Quality role focused on applying advanced analytics statistical methods and technology-enabled approaches to strengthen independent Quality oversight of clinical development participant protection patient safety and regulated research activities. This position requires practical expertise in clinical and patient-safety Quality and uses data as a means to identify emerging risks generate actionable quality insights and support timely evidence-based decisions by accountable GCP GVP GLP and GCLP Quality Leads. The role develops implements and maintains fit-for-purpose analytical methods and independent oversight-support tools tailored to regulated R&D activities. These may include statistical monitoring predictive risk models anomaly-detection methods patient-safety and adverse-event reporting analytics data-informed audit packages risk indicators dashboards automated monitoring natural-language tools and other scalable capabilities that support Quality by Design Risk-Based Quality Management audit and inspection readiness vendor process and system oversight and targeted risk mitigation. The position integrates and interprets complex clinical safety laboratory monitoring operational and quality data to identify study- site- subject- vendor- process- product- and portfolio-level signals that may affect participant protection patient safety data integrity scientific reliability or regulatory compliance. The role translates these signals into clear insights and recommendations for R&D Quality colleagues and cross-functional partners. Essential Functions of the Job R&D Quality Oversight and Risk Analytics Partner with R&D Quality leadership and GCP GVP GLP and GCLP stakeholders to identify priority quality questions emerging risks oversight gaps and opportunities for proactive intervention. Apply quality regulatory scientific and operational context to ensure analytical methods remain relevant to participant protection patient safety data integrity scientific validity and the reliability of regulated R&D activities. Conduct cross-study cross-program cross-vendor and cross-process analyses to identify recurring systemic or portfolio-level risks that may not be visible through individual study or functional review. Develop and maintain meaningful key quality indicators critical-to-quality factors quality tolerance limits risk indicators thresholds escalation criteria and portfolio surveillance methods aligned with RBQM and Quality by Design principles. Clinical Safety and Research Analytics Integrate and analyze relevant clinical study site subject safety pharmacovigilance laboratory monitoring audit inspection vendor system and quality data to support R&D Quality oversight. Develop analytical approaches to support data-informed audit planning/execution and identify potential patient-safety and subject-protection risks including adverse-event under-reporting or over-reporting unusual clinical-event patterns protocol-compliance concerns data-quality issues and other signals requiring targeted Quality review. Support GLP and GCLP oversight by developing analytics that identify trends and anomalies in research laboratory biomarker sample method data-flow and computerized-system activities as appropriate to the intended use and available data. Support GVP oversight through analytics related to safety reporting case processing signal-relevant quality indicators vendor performance timeliness completeness and other patient-safety process risks. Analytical Product Development and Maintenance Translate R&D Quality and business needs into clear analytical objectives data requirements functional specifications acceptance criteria implementation plans and measurable outcomes. Design develop test implement and maintain statistical packages analytical applications dashboards automated workflows predictive models and decision-support tools using SQL R Python Power BI and other approved technologies. Use automation machine learning natural-language processing generative AI or other emerging methods where they provide a justified fit-for-purpose improvement Data Quality Assurance and Lifecycle Governance Perform data profiling mapping cleaning transformation source-to-report reconciliation and root-cause analysis to confirm the accuracy completeness consistency timeliness and reliability of analytical outputs. Ensure analytical and AI-enabled solutions are appropriately governed through documented intended use data lineage testing validation or assurance access controls version control change management human review explainability performance monitoring and retirement planning proportionate to risk. Maintain appropriate technical and quality documentation to support reproducibility traceability inspection readiness and continued fitness for purpose in a regulated R&D environment. Partnership Communication and Capability Building Create executive-ready visualizations quality narratives risk summaries and recommendations that explain what the data means why it matters and what action should be considered. Support Quality Management Review portfolio quality surveillance RBQM governance audit planning inspection readiness vendor oversight computerized-system oversight and continuous improvement through timely and relevant analytical insights. Partner with Clinical Operations Clinical Development Data Management Biometrics Medical Monitoring Pharmacovigilance Regulatory Affairs laboratory functions RBQM Audit and Inspection Management Global Technology Solutions data engineering and enterprise platform teams. Lead or coordinate analytics workstreams from problem framing and data assessment through development testing implementation adoption monitoring and benefit realization. Stay current with global R&D regulatory expectations industry practices statistical methods responsible AI principles and emerging technologies relevant to GCP GVP GLP and GCLP Quality oversight. Additional Qualifications Experience in pharmaceutical biotechnology clinical research healthcare or another regulated life-sciences environment with demonstrated knowledge of R&D Quality clinical quality quality assurance compliance risk management or regulated research and development operations. Strong working knowledge of GCP and ICH requirements with familiarity or experience in GVP GLP GCLP data integrity computerized-system assurance and global R&D Quality expectations. Experience with structured and unstructured data data mapping data cleaning reconciliation transformation data modeling automated quality checks and data pipelines. Experience applying statistical analysis central statistical monitoring anomaly detection forecasting predictive modeling machine learning natural-language processing generative AI or related methods to practical clinical safety research or quality problems. Ability to understand complex R&D Quality and operational processes and translate them into scalable technical solutions without losing regulatory context scientific relevance or business usability. Ability to communicate technical findings clearly to nontechnical stakeholders and convert complex analyses into concise actionable quality recommendations. Other duties as assigned. Supervisory Responsibilities No direct people-management responsibility is required at this time. The position may provide technical leadership coaching and work direction to analysts contractors interns external vendors and cross-functional project teams. Computer Skills Advanced proficiency with SQL and hands-on proficiency with R or Python. Experience with Power BI or comparable visualization and business-intelligence platforms. Experience with statistical programming central monitoring anomaly detection predictive modeling or machine-learning tools and methods. Experience with APIs data warehouses cloud platforms ETL/ELT workflows Git or comparable version-control tools and analytical development environments. Experience with automation natural-language processing generative AI or model deployment and monitoring tools is preferred. Proficiency with Microsoft Office applications experience with clinical safety laboratory RBQM audit and quality platforms is preferred. Other Qualifications Communication & Interpersonal Skills Excellent written verbal presentation and interpersonal communication skills. Ability to collaborate effectively across global cross-functional clinical safety research quality data and technical teams. Ability to work with sensitive or confidential clinical safety quality laboratory and patient-level information in accordance with applicable requirements. Significant Contacts R&D Quality Leadership and all R&D Quality functions GCP GVP GLP and GCLP Quality teams Audit Management and Inspection Management Risk-Based Quality Management Clinical Operations Clinical Development Data Management Biometrics and Medical Monitoring Pharmacovigilance Regulatory Interacts with all levels of BeOne Travel May require up to 20% travel Salary Range Switzerland 141800.00 CHF - 177300.00 CHF Salary Range UK 74500.00 GBP - 93100.00 GBP Salary Range Germany 94500.00 EUR - 118100.00 EUR 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 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.