Senior Manager, R&D Quality Analytics – Portfolio Insights

This is a fully remote position, open to applicants in Switzerland, +2 more countries.

📋 Description

• Collaborate with R&D Quality leadership and stakeholders in GCP, GVP, GLP, and GCLP to pinpoint key quality inquiries, emerging risks, oversight deficiencies, and intervention possibilities.

• Apply quality, regulatory, scientific, and operational insights to analytical methodologies.

• Conduct analyses across studies, programs, vendors, and processes to uncover systemic and portfolio-wide risks.

• Create and sustain quality indicators, critical-to-quality factors, quality tolerance limits, risk indicators, thresholds, escalation criteria, and portfolio monitoring techniques.

• Integrate and evaluate clinical, safety, pharmacovigilance, laboratory, monitoring, audit, inspection, vendor, system, and quality data.

• Develop analytics for audit planning, patient safety, subject protection risks, GLP/GCLP oversight, and GVP oversight.

• Convert R&D Quality and business requirements into analytical objectives, data specifications, acceptance criteria, implementation strategies, and expected outcomes.

• Design, develop, test, implement, and maintain statistical packages, analytical applications, dashboards, automated workflows, predictive models, and decision-support tools.

• Utilize automation, machine learning, natural language processing, generative AI, and other emerging techniques where appropriate.

• Conduct data profiling, mapping, cleaning, transformation, reconciliation, and root cause analysis.

• Oversee analytical and AI-enabled solutions through comprehensive documentation, data lineage, testing, validation, access controls, version control, change management, human review, explainability, performance monitoring, and retirement planning.

• Maintain technical and quality documentation to ensure reproducibility, traceability, inspection readiness, and suitability for purpose.

• Generate 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 initiatives.

• Collaborate 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 identification through development, testing, implementation, adoption, monitoring, and realization of benefits.

• Stay updated with global R&D regulatory expectations, industry standards, statistical methods, responsible AI principles, and emerging technologies.

⛳️ Requirements

• Experience in pharmaceutical, biotechnology, clinical research, healthcare, or another regulated life sciences setting.

• Proven 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 guidelines.

• Familiarity or experience in GVP, GLP, GCLP, data integrity, computerized system assurance, and global R&D Quality expectations.

• Experience with structured and unstructured data, including data mapping, cleaning, reconciliation, transformation, data modeling, automated quality checks, and data pipelines.

• Experience in statistical analysis, central statistical monitoring, anomaly detection, forecasting, predictive modeling, machine learning, natural language processing, generative AI, or related methodologies.

• Capability to translate intricate R&D Quality and operational processes into scalable technical solutions.

• Ability to effectively communicate technical findings to non-technical stakeholders.

• Advanced proficiency in SQL and hands-on experience with R or Python.

• Experience with Power BI or similar visualization and business intelligence platforms.

• Familiarity with APIs, data warehouses, cloud platforms, ETL/ELT workflows, Git or similar version control tools, and analytical development environments.

• Proficient in Microsoft Office applications.

• Exceptional written, verbal, presentation, and interpersonal communication skills.

• Ability to collaborate across global, cross-functional clinical, safety, research, quality, data, and technical teams.

• Capability to handle sensitive or confidential information in compliance with applicable regulations.

• No direct people-management responsibilities required; may provide technical leadership, coaching, and work direction.

🏝️ Benefits

• Equal opportunity employment.

• Up to 20% travel may be necessary.