Director, Regulatory Data Governance & Inspection Readiness

Vertex Pharmaceuticals Incorporated; Boston (MA); Hybrid; USD 192,000 - 288,000; Full time

Job summary

Vertex Pharmaceuticals Incorporated is seeking a Director, Regulatory Data to lead strategy, governance, and execution of regulatory data management within Vertex's RIMS. You will oversee data collection, quality oversight, reporting, and inspection readiness, while developing a high-performing team and partnering cross-functionally to support portfolio decisions.

The role emphasizes establishing scalable data standards, driving continuous improvement, and ensuring data is complete, traceable,

Qualifications

• Bachelor's degree in life sciences or technology and 10+ years in pharma/biotech technology with 3+ years in supervision
• Experience leading regulatory data governance, quality, and reporting
• Strong leadership, communication, and stakeholder management across functions

Responsibilities

• Lead regulatory data governance, quality, and reporting programs
• Manage and develop the regulatory data team, setting objectives and priorities
• Oversee data collection, entry, maintenance, and reporting of regulatory information
• Ensure data quality, controls, and inspection readiness across systems
• Establish data governance standards and ownership models
• Drive inspection readiness and liaison support for audits
• Develop and deliver regulatory data metrics for leadership and governance forums
• Lead continuous improvement to strengthen data integrity and usability
• Identify and mitigate regulatory data risks
• Oversee onboarding and capability building for team and stakeholders

Skills

Leadership

Stakeholder mgmt

Change management

Project planning

Attention to detail

Communication

Cross-functional collaboration

Analytical skills

People management

Education

Bachelor's degree in life sciences or technology

Tools

Regulatory Information Management (RIMS)

Job description

Vertex Pharmaceuticals Incorporated is seeking a Director, Regulatory Data to lead strategy, governance, and execution of regulatory data management within Vertex's RIMS. You will oversee data collection, quality oversight, reporting, and inspection readiness, while developing a high-performing team and partnering cross-functionally to support portfolio decisions.

The role emphasizes establishing scalable data standards, driving continuous improvement, and ensuring data is complete, traceable,