Senior Manager, R&D Quality Analytics, Portfolio Insights

This is a fully remote position, open to applicants in United States.

📋 Description

• Utilize advanced analytics, statistical techniques, and technology-driven methods to enhance independent R&D Quality oversight.

• Recognize emerging risks and provide actionable quality insights for evidence-based decision-making by GCP, GVP, GLP, and GCLP Quality Leads.

• Create, implement, and sustain analytical methods and oversight-support tools for regulated R&D activities.

• Synthesize and analyze clinical, safety, laboratory, monitoring, operational, and quality data to pinpoint signals at the study, site, subject, vendor, process, product, and portfolio levels.

• Collaborate with R&D Quality leadership and stakeholders to determine priority quality inquiries, emerging risks, oversight deficiencies, and intervention possibilities.

• Execute cross-study, cross-program, cross-vendor, and cross-process risk assessments.

• Formulate key quality indicators, critical-to-quality factors, quality tolerance limits, risk indicators, thresholds, escalation criteria, and portfolio monitoring methods.

• Evaluate clinical study, safety, pharmacovigilance, laboratory, monitoring, audit, inspection, vendor, system, and quality data.

• Generate analytics to support 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.

• Carry out 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.

• Produce executive-ready visualizations, quality narratives, risk summaries, and recommendations.

• Assist in Quality Management Review, portfolio monitoring, RBQM governance, audit planning, inspection preparedness, vendor oversight, computerized-system oversight, and continuous improvement.

• 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 to benefits realization.

• Keep abreast of global R&D regulatory standards, statistical methodologies, responsible AI, and emerging technologies.

• Provide technical leadership, guidance, and direction to analysts, contractors, interns, vendors, and project teams.

• Travel up to 20% may be required.

⛳️ Requirements

• Experience in the pharmaceutical, biotechnology, clinical research, healthcare, or another regulated life-sciences sector.

• Proven expertise in R&D Quality, clinical quality, quality assurance, compliance, risk management, or regulated R&D operations.

• Strong understanding of GCP and ICH requirements.

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

• Experience with structured and unstructured data, including 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 challenges.

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

• Ability to convey technical findings to non-technical stakeholders and produce actionable quality recommendations.

• Advanced proficiency in SQL.

• Hands-on proficiency in R or Python.

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

• Experience with statistical programming, central monitoring, anomaly detection, predictive modeling, or machine-learning tools and methodologies.

• Familiarity with APIs, data warehouses, cloud platforms, ETL/ELT workflows, Git or similar version-control systems, 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.

• Capacity to manage sensitive or confidential clinical, safety, quality, laboratory, and patient-level information in accordance with applicable regulations.

• No direct people-management responsibilities are required.

🏝️ Benefits

• Eligibility for an annual bonus plan 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.

• Opportunities for technical leadership, coaching, and work direction.