Sr Director, ERP GMP Quality Lead
Core
Provide independent GMP quality leadership and oversight for the design, deployment, and operation of enterprise resource planning (ERP) solutions supporting regulated business processes in the pharmaceutical industry.
Role type
Sr Director, ERP GMP Quality Lead
Builds
Enterprise resource planning (ERP) systems and processes for quality planning, batch disposition, material quality, and regulated master data.
Domain
Pharmaceutical / Biotechnology / GxP / Computerized System Validation
Required skills
GMP compliance, Computerized System Validation (CSV), Data Integrity, Quality Risk Management, Change Control, Deviation/CAPA management, SAP S/4HANA knowledge, Global matrix organization leadership
Preferred skills
Advanced degree in Quality/Auditing, SAP QM/Batch Management experience, Global deployment/M&A experience, Process modeling
Technologies
SAP S/4HANA, ERP systems, GxP systems
Responsibilities
Serve as the primary GMP Quality authority for ERP program decisions; Guide global process owners in defining standardized, compliant ERP processes; Partner with software suppliers to align product roadmaps with Gilead's GMP goals; Ensure GMP controls operate effectively across Manufacturing, Supply Chain, and connected applications; Own and approve business requirements for Quality processes and validate critical controls; Establish and maintain Quality governance for ERP design decisions, risks, and lifecycle changes; Define and monitor Quality and compliance KPIs for validation and release readiness.
Seniority
Senior, hands-on IC with strategic oversight
