Sr Director, ERP GMP Quality Lead

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Sr. Director, ERP GMP Quality Lead

Role Overview

The ERP GMP Quality Lead provides quality leadership and independent GMP oversight for the design, deployment, and operation of enterprise resource planning solutions supporting regulated business processes for the Quality Business Processes.

This role ensures ERP processes and controls are fit for intended use, compliant, standardized where appropriate, and supported by proportionate risk-based assurance across sites, functions, regions, and integrated systems. The lead partners with Quality, Business, IT, Data, Security, and Validation stakeholders to enable compliant and sustainable transformation.

The role covers GMP-relevant ERP capabilities including quality planning and inspection, batch disposition and release support, quality notifications, material and supplier quality, manufacturing and warehouse integration, regulated master data, electronic records and signatures, reporting, interfaces, and integrations with laboratory, regulatory, and other GxP systems.

Key Responsibilities

1. GMP Quality Leadership and Oversight

• Serve as the Quality lead for ERP program decisions affecting GMP processes, data, records, controls, and regulated operations
• Provide independent, risk-based Quality oversight from process design through deployment, stabilization, and ongoing operation
• Ensure alignment with applicable GMP requirements, the pharmaceutical quality system, data integrity principles, and approved quality and validation strategies

2. Process Design & Standardization

• Guide global process owners and design teams in defining standardized, compliant, and scalable ERP processes
• Assess process and control designs for compliance risk, data integrity, segregation of duties, traceability, and operational effectiveness
• Ensure local regulatory or business requirements are addressed through governed exceptions rather than unnecessary process variation
• Maintain GMP Quality design principles, critical controls, acceptance criteria, and decision records

3. Industry and Vendor Partnership

• Develop and maintain connection to industry groups related to GMP topics in ERP to evaluate industry solutions to Gilead ERP needs, and to influence industry feedback to software suppliers.
• Partner with software suppliers and vendors to ensure product roadmaps include features that align with Gilead’s strategic EPP GMP goals.
• Identify and evaluate GMP ERP platforms, tools and solutions to build novel ways of meeting Gilead’s business goals.

4. Cross-Functional Quality Integration

• Partner with ERP process leads, business owners, IT architects, data leads, cybersecurity, validation, and site Quality organizations
• Ensure GMP controls operate effectively across Manufacturing, Supply Chain, Procurement, Warehouse, Laboratory, Regulatory, Finance, and connected applications
• Assess upstream and downstream quality impacts of process, configuration, data, interface, and deployment decisions
• Escalate unresolved patient, product quality, compliance, or data integrity risks through established governance

5. Computerized System Validation

• Owns and Approves business requirements for Quality processes
• Confirm that critical requirements and controls are verified with objective evidence and that defects and residual risks are appropriately resolved or accepted
• Approve GMP readiness for releases, deployments, major changes, and transition to operations in accordance with delegated authority

6. Deployment, Change Control, and Operational Readiness

• Ensure ERP deployments comply with approved change control, validation, data migration, cutover, training, and procedural readiness requirements
• Review readiness evidence, including open defects, deviations, user access, master data, interfaces, business continuity, support, and rollback plans

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