R&D Quality Senior Manager

Vertex Inc.•Boston, MA

7d•Hybrid

About The Position

The Sr. Manager, R&D Quality (RDQ) Governance & Risk Management plays a critical role in Vertex’s R&D Quality value chain by driving a holistic, proactive, and end-to-end approach to quality risk management (QRM) across clinical development. This role ensures that risk-based thinking is embedded into R&D processes, decisions, and governance. The Sr. Manager is responsible for partnering across R&D functions to ensure proactive identification, assessment, and mitigation of quality risks spanning GCP, GVP, GLP, and broader R&D Quality domains. This individual partners closely with R&D functional leaders, process owners, and governance bodies to influence decision-making, support strategic mitigation planning, and enhance the reliability of clinical trial execution while ensuring patient privacy & safety, regulatory compliance, and clinical trial data integrity. This role requires strategic considerations balanced with hands-on execution. The Sr. Manager will strengthen the infrastructure of R&D quality risk management, support R&D governance implementation and management, including Quality Management Review, and enhance risk transparency, through data, analytics, and standardized tools while maintaining a continuous state of inspection readiness for all programs.

Requirements

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

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 the 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.