R&D Quality Senior Manager

Role Summary

The Senior Manager, R&D Quality Governance & Risk Management drives a proactive, end-to-end quality risk management approach across clinical development, embedding risk-based thinking into R&D processes, decisions, and governance. You will partner with R&D functional leaders to identify, assess, and mitigate quality risks across GCP, GVP, GLP, and broader R&D domains, supporting governance structures and Quality Management Reviews to enhance trial reliability, patient safety, regulatory compliance, and data integrity. The role combines strategic planning with hands-on execution to strengthen R&D quality risk management infrastructure, enable risk transparency through data and standardized tools, and maintain inspection readiness across programs. Location: Hybrid-Eligible or On-Site Eligible.

Responsibilities

• Lead, influence, and continuously improve R&D Quality’s risk management elements within the enterprise Risk Management Framework, including risk scoring methodology, definitions, and quality governance structures.
• Maintain and evolve standardized R&D QRM documentation and associated risk management systems and tools ensuring a continuous state of inspection readiness.
• Drive consistent development, refinement, and lifecycle management of risk plans and mitigations across R&D programs, systems, and process domains.
• Serve as a subject matter expert (R&D Quality Risk Champion) for QRM practices and software, industry expectations, and evolving regulatory trends.
• Build and maintain strong stakeholder and business partner relationships while ensuring consistent, data-driven risk-based decision making across all functions of R&D.
• Partner with R&D business functions (e.g., Global Clinical Operations, Biomarkers, Vendor Management, Regulatory, Legal, Compliance) to proactively identify, assess, prioritize, and mitigate quality risks.
• Collaborate with Compliance & Issue Management, Clinical Quality Oversight, R&D Analytics, and Operational Governance teams to ensure a unified and effective risk oversight model.
• Facilitate risk reviews, program-level discussions, and cross-functional risk alignment meetings.
• Provide guidance on risk mitigation strategies and ensure appropriate escalation, documentation, and follow-through.
• Prepare and present risk insights, dashboards, and metrics for RDQ governance bodies, Quarterly Quality Reviews, and senior leadership forums, such as QMR.
• Drive awareness and adoption of risk management principles across RDQ and R&D functions.
• Develop, refine, and deploy risk management tools, templates, and processes that support operational consistency and regulatory expectations.
• Leverage data-driven approaches and predictive analytics to enhance visibility, early warning, and trend identification.
• Contribute to unified governance initiatives by aligning risk management practices with enterprise governance frameworks.
• Identify opportunities for simplification, modernization, and improved integration of risk activities across R&D Quality.

Qualifications

• 5+ yrs experience in Pharmaceutical / Biotech / Medical Device Quality Assurance / Compliance
• Experience with GxP risk management
• Ability to analyze complex scenarios, synthesize data, and generate clear, actionable summaries and recommendations to leadership.
• Experience with risk assessment approaches, quality systems, and Quality governance structures.
• Strong communication and project management skills
• Proficiency with project management tools