Senior Director - Quality Data, Digital Systems & Compliance

Vertex Pharmaceuticals · Boston, MA

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QualityFull-time$228k–$342kCompany career page

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Role summary

Senior Director role leading enterprise-wide GxP data governance, data integrity, master data management, computerized systems compliance, and quality analytics. This strategic position partners across Quality, IT, Regulatory, and business functions to establish robust frameworks, ensure regulatory compliance, and drive data-driven decision-making in a regulated pharmaceutical environment.

What they're looking for

BS, MS, JD, MD, or PhD in Life Sciences, Engineering, Information Systems, Computer Science, or Quality discipline
15 years relevant work experience with 7 years in leadership/supervisory role in global organization
GMP, GCP, or IT operational/quality experience in regulated environment
Advanced expertise in data integrity, governance, and computer systems assurance strategies
Knowledge of 21 CFR Part 11, Annex 11, and global computerized systems requirements
Demonstrated experience building enterprise data quality standards, analytics, and predictive models
Change management and quality leadership capabilities in scaling organizations

What you'll be doing

Advance and scale enterprise GxP Data Governance framework, policies, standards aligned with ALCOA+ principles
Provide strategic direction for master data management model and quality-related master data oversight across GxP functions
Define data quality standards, metrics, controls, and embed proactive surveillance and remediation programs
Ensure computerized systems compliance with regulatory requirements and govern validation methodologies and lifecycle management
Develop quality analytics vision, data models, dashboards, and predictive analytics to support compliance and organizational decision-making

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