R&D Quality Governance & Risk Management Director

Vertex Inc. • Boston, MA

1d • Hybrid

About The Position

General position summary: The Director of R&D Quality Governance & Risk Management will serve as a strategic leader and trusted partner within R&D Quality, responsible for shaping, implementing, and continuously improving the governance framework that supports risk-based decision-making across Vertex’s R&D portfolio. This role will integrate governance excellence, enterprise risk management, and clinical quality management system expertise to drive a unified “One State of Quality” operating model. This individual will also function as a key thought partner and execution lead to the Senior Director—able to synthesize complex information, generate actionable insights, and translate strategy into clear next steps and high-quality deliverables. The ideal candidate brings deep R&D Quality experience, strong leadership presence, operational agility, exceptional collaboration skills, and the ability to both guide and personally execute work across diverse stakeholders and priorities.

Requirements

• Bachelor’s degree in scientific or technical discipline; advanced degree preferred.
• 10+ years of experience in R&D QA, Clinical Quality, Quality Systems, or related functions.
• Experience leading governance structures, QMS/QMR, or enterprise quality programs.
• Strong knowledge of ICH, GCP, and risk management principles.
• Exceptional communication and executive presentation skills.
• Ability to lead cross-functional efforts and deliver high-quality outcomes in dynamic environments.
• Ability to mentor and develop team capabilities.

Nice To Haves

• Experience building or maturing QMS frameworks and familiarity with quality health indicators, data/analytics for QRM, and governance platforms preferred.

Responsibilities

• Lead the design, implementation, and continuous enhancement of the R&D Quality governance structure.
• Serve as the operational owner of governance forums, establishing standards for cadence, documentation, and information flow.
• Coordinate priorities, actions, and follow-through across the RDQ LT.
• Partner with Compliance, Inspection Readiness, Clinical Quality Oversight, and Quality Systems to integrate key insights into governance forums.
• Provide strategic direction for risk identification, evaluation, and mitigation across R&D.
• Lead enhancements to QRM tools, risk heatmaps, templates, and processes.
• Mentor QRM leads and SMEs to ensure consistent application of risk principles aligned to global expectations.
• Support decision-making through synthesis of risk signals and cross-functional inputs.
• Drive creation and refinement of R&D Quality’s contributions to the enterprise QMR.
• Ensure alignment of R&D quality processes with CQMS expectations and regulations.
• Facilitate visibility into quality performance metrics and readiness indicators.
• Act as a “go-to” partner to the Senior Director for strategy, framing issues, and driving clarity.
• Synthesize diverse inputs into coherent recommendations and executive-ready deliverables.
• Lead or support cross-functional initiatives and change management efforts.
• Model collaborative leadership and influence across all levels of the organization.

Benefits

• At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.
• From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 1,001-5,000 employees