Senior Manager, R&D Quality Analytics, Portfolio Insights

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BeOne Medicines

WebsiteLinkedInAlle Stellen

10.000+ Mitarbeiter

Gegründet 2010

🧬 Biotechnologie

🏥 Gesundheitswesen

💊 Pharmazie

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines ist ein globales Onkologieunternehmen mit Sitz in der Schweiz, das innovative Therapien entdeckt und entwickelt, die für Krebspatientinnen und -patienten weltweit erschwinglicher und besser zugänglich sind. Mit einem Portfolio, das Hämatologie und solide Tumoren abdeckt, beschleunigt BeOne die Entwicklung seiner vielfältigen Pipeline neuartiger Therapeutika durch interne Kompetenzen und Kooperationen. Mit einem globalen Team von mehr als 11.000 Mitarbeitenden auf sechs Kontinenten setzt sich das Unternehmen dafür ein, den Zugang zu Arzneimitteln für deutlich mehr Patientinnen und Patienten, die sie benötigen, grundlegend zu verbessern.

Beschreibung

• Apply advanced analytics, statistical methods, and technology-enabled approaches to strengthen independent R&D Quality oversight • Identify emerging risks and generate actionable quality insights for evidence-based decisions by GCP, GVP, GLP, and GCLP Quality Leads • Develop, implement, and maintain analytical methods and oversight-support tools for regulated R&D activities • Integrate and interpret clinical, safety, laboratory, monitoring, operational, and quality data to identify study-, site-, subject-, vendor-, process-, product-, and portfolio-level signals • Partner with R&D Quality leadership and stakeholders to identify priority quality questions, emerging risks, oversight gaps, and intervention opportunities • Conduct cross-study, cross-program, cross-vendor, and cross-process risk analyses • Develop key quality indicators, critical-to-quality factors, quality tolerance limits, risk indicators, thresholds, escalation criteria, and portfolio surveillance methods • Analyze clinical study, safety, pharmacovigilance, laboratory, monitoring, audit, inspection, vendor, system, and quality data • Develop analytics supporting audit planning, patient-safety risk identification, GLP/GCLP oversight, and GVP oversight • Design, develop, test, implement, and maintain statistical packages, analytical applications, dashboards, automated workflows, predictive models, and decision-support tools • Perform data profiling, mapping, cleaning, transformation, reconciliation, and root-cause analysis • Govern analytical and AI-enabled solutions through intended-use documentation, lineage, testing, validation or assurance, access controls, version control, change management, human review, explainability, monitoring, and retirement planning • Create executive-ready visualizations, quality narratives, risk summaries, and recommendations • Support Quality Management Review, portfolio surveillance, RBQM governance, audit planning, inspection readiness, vendor oversight, computerized-system oversight, and continuous improvement • Partner with Clinical Operations, Clinical Development, Data Management, Biometrics, Medical Monitoring, Pharmacovigilance, Regulatory Affairs, laboratory, RBQM, audit, technology, data engineering, and platform teams • Lead or coordinate analytics workstreams from problem framing through benefit realization • Stay current with global R&D regulatory expectations, statistical methods, responsible AI, and emerging technologies • Provide technical leadership, coaching, and work direction to analysts, contractors, interns, vendors, and project teams • Travel up to 20% may be required

🎯 Anforderungen

• Experience in pharmaceutical, biotechnology, clinical research, healthcare, or another regulated life-sciences environment • Demonstrated knowledge of R&D Quality, clinical quality, quality assurance, compliance, risk management, or regulated R&D operations • Strong working knowledge of GCP and ICH requirements • Familiarity or experience with GVP, GLP, GCLP, data integrity, computerized-system assurance, and global R&D Quality expectations • Experience with structured and unstructured data, data mapping, cleaning, reconciliation, transformation, modeling, automated quality checks, and data pipelines • Experience applying statistical analysis, central statistical monitoring, anomaly detection, forecasting, predictive modeling, machine learning, NLP, generative AI, or related methods to clinical, safety, research, or quality problems • Ability to translate complex R&D Quality and operational processes into scalable technical solutions • Ability to communicate technical findings to nontechnical stakeholders and produce actionable quality recommendations • Advanced proficiency with SQL • 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 • Proficiency with Microsoft Office applications • Excellent written, verbal, presentation, and interpersonal communication skills • Ability to collaborate across global, cross-functional, clinical, safety, research, quality, data, and technical teams • Ability to handle sensitive or confidential clinical, safety, quality, laboratory, and patient-level information in accordance with applicable requirements • No direct people-management responsibility is required

🏖️ Vorteile

• Annual bonus plan eligibility for non-commercial roles • Discretionary equity awards • Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life insurance • Paid Time Off • Wellness benefits • Remote work arrangement • Technical leadership, coaching, and work-direction opportunities