Overview
In this role you will apply advanced analytics to strengthen independent quality oversight of regulated R&D activities. You drive data-informed insights to protect participants and support compliant decisions across GCP, GVP, GLP, and GCLP. You will develop scalable analytics and tools that enable risk monitoring, quality indicators, and portfolio surveillance. This role partners across R&D Quality and cross-functional teams to translate signals into actionable recommendations that advance patient safety and data integrity.
Verantwortungsbereiche
- Identify priority quality questions and emerging risks with leadership and stakeholders
- Develop and maintain quality indicators, risk indicators, thresholds, and portfolio surveillance methods aligned with RBQM and QbD
- Integrate clinical, safety, laboratory, monitoring, vendor, and quality data to support oversight
- Design and maintain analytical products: statistical packages, dashboards, predictive models, and decision-support tools
- Support audit planning, inspection readiness, and risk-based quality management through analytics
- Translate business needs into analytical objectives, data requirements, and implementation plans
- Lead or coordinate analytics workstreams from problem framing to adoption and benefit realization
- Stay current with global regulatory expectations and emerging analytics technologies
- Ensure governance, data lineage, validation, and explainability for AI-enabled solutions
- Collaborate across clinical operations, data management, pharmacovigilance, regulatory affairs, and IT teams
- Provide executive-ready narratives and visuals explaining data insights and actions
- Travel up to 20% as needed
Zentrale Anforderungen
- Experience in pharma/biotech/regulated life sciences with knowledge of R&D quality and regulatory requirements
- Strong knowledge of GCP and ICH; familiarity with GVP, GLP, GCLP, data integrity, and quality expectations
- Experience with structured and unstructured data, data cleaning, mapping, reconciliation, transformation, and data pipelines
- Experience applying statistics, central monitoring, anomaly detection, predictive modeling, ML, NLP, or related methods to clinical/quality problems
- Ability to translate complex R&D quality processes into scalable technical solutions without losing regulatory context
- Strong communication skills to present technical findings to nontechnical stakeholders
- collaborative
- communication
- problem-solving
- SQL
- R
- Python
Senior Manager R&D Quality Analytics & Portfolio Insights in Heilbronn Arbeitgeber: BeiGene
BeOne ist ein hervorragender Arbeitgeber, der eine dynamische und unterstützende Arbeitsumgebung bietet, in der Mitarbeiter ihre Fähigkeiten weiterentwickeln und an bedeutenden Projekten zur Bekämpfung von Krebs mitwirken können. Mit einem klaren Fokus auf kontinuierliches Lernen und Entwicklung fördert BeOne eine Kultur der Zusammenarbeit und Innovation, während die strategische Lage in Deutschland den Zugang zu einem breiten Netzwerk von Fachleuten und Ressourcen ermöglicht. Die Möglichkeit, an der Gestaltung von Schulungsprogrammen für neue Produkte und Marktstrategien mitzuwirken, macht diese Position besonders attraktiv für engagierte Fachkräfte.
