Associate Director, Digital Quality Compliance
Core
Business system owner and leader for Quality digital capabilities, shaping enterprise Quality technologies (SAP, Veeva, LIMS) and enabling compliant, efficient, and scalable Quality operations.
Role type
Senior IC business system owner (Quality Compliance)
Builds
Enterprise Quality systems (SAP, Veeva, LIMS, DocuSign) and integrated platforms
Domain
Life Sciences / Pharmaceutical Quality Management Systems (GxP)
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
GxP compliance knowledge, SAP/Veeva/LIMS functional expertise, system roadmap planning, cross-functional stakeholder management, data governance, validation strategy, process standardization
Preferred skills
Experience with Quality Insights & Analytics, IT system feature evaluation, release planning and change control
Technologies
SAP, Veeva Vault Quality, LIMS, DocuSign, Kneat, Quality Insights & Analytics Dashboards
Responsibilities
Lead multi-year roadmap for Quality digital capabilities; Drive prioritization and delivery of Quality capability improvements through governance forums; Provide Quality business ownership for QA/QC digital capabilities; Serve as primary translator between Quality and IT/SAP & Veeva Center of Excellence teams; Drive standardization and simplification of Quality processes; Evaluate impact of IT System new features, modules, and capabilities; Support Quality data governance and standards; Support release planning and change control for QA/QC systems; Ensure high-quality, inspection-ready documentation; Provide guidance to Quality users on compliant system use; Lead periodic Quality reviews of system performance and compliance posture; Contribute to validation strategy and planning; Coordinate with owners of other Veeva Vaults and GxP systems; Facilitate governance forums for Quality and Technical Operations Quality capability requests
Seniority
Senior, hands-on IC