Associate Director/Director, Digital Quality
Core
Process Owner for R&D Data and Records Integrity and Business Owner for key quality technology systems, ensuring data governance, AI oversight, and compliance with regulations.
Role type
Senior IC Quality Director (Data Governance & AI Oversight)
Builds
Data governance frameworks, AI risk assessment strategies, and cross-functional data migration/digitization initiatives.
Domain
Pharmaceutical R&D, Data Integrity, AI/ML Governance
Required skills
GxP quality assurance, data integrity (ALCOA+), computer system validation, AI/ML risk concepts, data governance artifact creation, SOP governance, change control management
Preferred skills
Regulatory inspection representation, cross-functional leadership, strategic planning for data governance
Technologies
Veeva Quality Docs, DocuSign Part 11
Responsibilities
Own and maintain the R&D data governance framework and inventory of R&D data and AI applications; Apply risk assessments and control strategies for computerized systems and AI tools; Drive strategy for large cross-functional data migration and digitization projects; Represent Quality Governance in regulatory inspections and third-party audits; Oversee Quality Events, Investigations, and CAPAs.
Seniority
Director, hands-on IC with strategic oversight
