Senior Director - Quality Data, Digital Systems & Compliance
Core
Strategic leader establishing frameworks for GxP data integrity, master data management, computer systems compliance, and quality analytics to ensure regulatory compliance and inspection readiness.
Role type
Senior Director, Quality Data & Compliance (Strategy & Leadership)
Builds
Enterprise GxP data governance frameworks, data quality surveillance programs, computerized systems compliance oversight, and quality analytics dashboards.
Domain
Life Sciences / Regulated Manufacturing / Quality Management Systems (QMS)
Deliverable
production ML models | dashboards & analysis | infrastructure
Required skills
Strategic leadership, GxP data integrity (ALCOA+), Master Data Management (MDM), Computer Systems Assurance (CSV/CSA), Quality Analytics, Risk Management, Change Management, Cross-functional stakeholder engagement
Preferred skills
Digital transformation, Advanced analytics, Predictive modeling, Organizational change leadership
Technologies
QMS, Data Governance Tools, BI Platforms, Computerized Systems
Responsibilities
Advance enterprise GxP Data Governance frameworks and policies; Provide strategic direction for GxP Data Integrity and Master Data Management; Define data quality standards and monitoring processes; Oversee computerized systems compliance (21 CFR Part 11, Annex 11) and validation methodologies; Drive quality analytics vision and performance metrics; Lead quality culture and mentor professionals.
Seniority
Senior Director, hands-on strategic leadership