Vertex · 5 hours ago
R&D Quality Governance & Risk Management Director
Vertex is a global biotechnology company that invests in scientific innovation, and they are seeking a Director of R&D Quality Governance & Risk Management. This role will involve shaping and implementing a governance framework that supports risk-based decision-making across Vertex’s R&D portfolio while driving collaboration and quality management across diverse stakeholders.
Computer Software
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
Qualification
Required
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
Preferred
Experience building or maturing QMS frameworks and familiarity with quality health indicators, data/analytics for QRM, and governance platforms
Benefits
Medical, dental and vision benefits
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)
Company
Vertex
Vendor intelligence that combs through your supplier, manufacturer, logistics data to detect where you're leaving money on the table.
H1B Sponsorship
Vertex has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (27)
2024 (18)
2023 (7)
2022 (13)
2021 (5)
2020 (7)
Funding
Current Stage
Early StageCompany data provided by crunchbase