Senior Manager, R&D Quality Analytics – Portfolio Insights

🕒 il y a 4 jours

🌐 Suisse, Royaume-Uni, +1 autres pays – Distant

🇨🇭 Suisse – Télétravail 🇬🇧 Royaume-Uni – Télétravail 🇩🇪 Allemagne – Télétravail

💵 CHF141 800 - CHF177 300 / an

⏰ Temps Plein

🟠 Senior

👔 Manager

👻 Score fantôme 1%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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BeOne Medicines

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 2010

🧬 Biotechnologie

🏥 Santé

💊 Pharmaceutique

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines est une entreprise mondiale d’oncologie dont le siège est en Suisse. Elle découvre et développe des traitements innovants, plus abordables et plus accessibles aux patients atteints de cancer dans le monde entier. Avec un portefeuille couvrant l’hématologie et les tumeurs solides, BeOne accélère le développement de son pipeline diversifié de nouvelles thérapies grâce à ses capacités internes et à ses collaborations. Forte d’une équipe mondiale en croissance de plus de 11 000 collaborateurs présents sur six continents, l’entreprise s’engage à améliorer radicalement l’accès aux médicaments pour un bien plus grand nombre de patients qui en ont besoin.

Description

• Partner with R&D Quality leadership and GCP, GVP, GLP, and GCLP stakeholders to identify priority quality questions, emerging risks, oversight gaps, and intervention opportunities • Apply quality, regulatory, scientific, and operational context to analytical methods • Conduct cross-study, cross-program, cross-vendor, and cross-process analyses to identify systemic and portfolio-level risks • Develop and maintain quality indicators, critical-to-quality factors, quality tolerance limits, risk indicators, thresholds, escalation criteria, and portfolio surveillance methods • Integrate and analyze clinical, safety, pharmacovigilance, laboratory, monitoring, audit, inspection, vendor, system, and quality data • Develop analytics for audit planning, patient-safety and subject-protection risks, GLP/GCLP oversight, and GVP oversight • Translate R&D Quality and business needs into analytical objectives, data requirements, specifications, acceptance criteria, implementation plans, and outcomes • Design, develop, test, implement, and maintain statistical packages, analytical applications, dashboards, automated workflows, predictive models, and decision-support tools • Use automation, machine learning, natural-language processing, generative AI, and emerging methods where fit for purpose • Perform data profiling, mapping, cleaning, transformation, reconciliation, and root-cause analysis • Govern analytical and AI-enabled solutions through intended-use documentation, data lineage, testing, validation or assurance, access controls, version control, change management, human review, explainability, performance monitoring, and retirement planning • Maintain technical and quality documentation for reproducibility, traceability, inspection readiness, and fitness for purpose • Create executive-ready visualizations, quality narratives, risk summaries, and recommendations • Support Quality Management Review, portfolio quality 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 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

🎯 Exigences

• 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 research and development operations • Strong working knowledge of GCP and ICH requirements • 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 • Ability to translate complex R&D Quality and operational processes into scalable technical solutions • Ability to communicate technical findings clearly to nontechnical stakeholders • 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 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 work with sensitive or confidential information in accordance with applicable requirements • No direct people-management responsibility is required; may provide technical leadership, coaching, and work direction

🏖️ Avantages

• Equal opportunity employment • Up to 20% travel may be required