R&D Quality Governance & Risk Management Director

Job Description

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 Vertexs 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 Directorable 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.

Key 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 Qualitys 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.

Qualifications & Experience:

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

Competencies

• Strategic and enterprise thinking
• Cross-functional collaboration
• Clarity in ambiguity
• Execution excellence
• Leadership presence
• Change agility

#LI-Hybrid

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Hybrid

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry ethnicity disability veteran status genetic information sexual orientation marital status or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager or contact Talent Acquisition at