Senior Manager R&D Quality Analytics & Portfolio Insights

Accountabilities

• Develop and implement advanced analytical approaches that enhance independent quality oversight across regulated research and development activities.
• Focus on identifying emerging risks, building scalable analytics solutions, and translating complex data into meaningful quality insights that support proactive decision-making.
• Partner with R&D Quality leaders and cross-functional stakeholders to identify quality priorities, oversight opportunities, emerging risks, and areas requiring proactive intervention.
• Develop and maintain analytical frameworks, quality indicators, risk signals, thresholds, and monitoring approaches aligned with risk-based quality management and Quality by Design principles.
• Analyze clinical, safety, laboratory, monitoring, vendor, audit, operational, and quality data to identify study-level, program-level, and portfolio-level trends.
• Create statistical monitoring approaches, predictive models, anomaly detection methods, dashboards, and automated solutions to support quality oversight.
• Design and maintain analytical tools using technologies such as SQL, R, Python, Power BI, and other approved platforms.
• Translate business and quality requirements into analytical objectives, data specifications, implementation plans, and measurable outcomes.
• Perform data profiling, transformation, reconciliation, and root-cause analysis to ensure accuracy, reliability, and consistency of analytical outputs.
• Support patient safety monitoring by identifying potential risks related to adverse-event reporting, protocol compliance, data quality, and operational performance.
• Apply analytics to support GCP, GVP, GLP, and GCLP oversight activities, including audit readiness, vendor oversight, and inspection preparation.
• Establish governance practices for analytical and AI-enabled solutions, including documentation, validation, explainability, access controls, and lifecycle management.
• Create executive-level reports, visualizations, and recommendations that communicate quality risks and opportunities clearly.
• Lead analytics initiatives from initial problem definition through development, implementation, adoption, and continuous improvement.
• Collaborate with Clinical Operations, Clinical Development, Data Management, Biometrics, Pharmacovigilance, Regulatory Affairs, technology teams, and other stakeholders.
• Stay current with regulatory expectations, industry trends, statistical methods, responsible AI practices, and emerging technologies relevant to R&D quality.

Requirements

• Experience in pharmaceutical, biotechnology, clinical research, healthcare, or another regulated life sciences environment.
• Strong knowledge of R&D Quality, clinical quality, quality assurance, compliance, risk management, or regulated research operations.
• Strong understanding of GCP and ICH requirements, with familiarity with GVP, GLP, GCLP, data integrity, and computerized system assurance.
• Experience working with structured and unstructured data, including data mapping, cleaning, transformation, reconciliation, and modeling.
• Hands-on experience applying statistical analysis, central monitoring, anomaly detection, predictive analytics, machine learning, natural language processing, or generative AI to healthcare or quality-related challenges.
• Advanced proficiency with SQL and practical experience using R or Python.
• Experience with Power BI or similar business intelligence and data visualization platforms.
• Familiarity with APIs, cloud platforms, ETL/ELT workflows, data warehouses, Git or comparable version-control systems, and analytical development environments.
• Ability to translate complex R&D processes into scalable analytical solutions while maintaining regulatory and scientific relevance.
• Strong written, verbal, and presentation skills, with the ability to communicate technical findings to non-technical stakeholders.
• Ability to collaborate effectively across global, multidisciplinary teams.
• Ability to handle confidential clinical, safety, quality, and patient-related information appropriately.
• Strong analytical thinking, problem-solving abilities, and attention to detail.
• Ability to provide technical leadership and guidance to project teams, vendors, contractors, or analysts.
• Willingness to travel up to 20%.

Benefits

• Competitive salary ranges depending on location: Switzerland approximately CHF 141,800 - CHF 177,300 annually; United Kingdom approximately £74,500 - £93,100 annually; Germany approximately €94,500 - €118,100 annually.
• Opportunity to work remotely within eligible locations.
• Global, collaborative work environment supporting innovative healthcare solutions.
• Professional development opportunities and continuous learning culture.
• Exposure to advanced analytics, AI technologies, and cutting-edge research initiatives.
• Opportunity to contribute to projects focused on improving patient safety and healthcare outcomes.
• Inclusive workplace culture centered on teamwork, innovation, and excellence.
• Opportunities to collaborate with international teams across research, quality, technology, and healthcare functions.