Senior Director - Quality Data, Digital Systems & Compliance

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.

Responsibilities

• 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

Requirements

• 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