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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
- Support go-live decisions, hypercare, issue triage, and transition to validated operations
- Ensure changes after go-live remain controlled through the system lifecycle
7. Governance & Compliance
- Establish and maintain Quality governance for ERP design decisions, risks, exceptions, releases, and lifecycle changes
- Ensure compliance with internal quality systems and applicable regulatory expectations for computerized systems and electronic records
- Support inspection readiness, regulatory inspections, internal audits, and responses related to ERP processes and controls
- Drive timely investigation and remediation of quality events, control failures, and audit observations
8. Performance Monitoring & Continuous Improvement
- Define and monitor Quality and compliance KPIs for validation, release readiness, deviations, defects, access, data integrity, and control effectiveness
- Use trends and risk signals to prioritize corrective actions and continuous improvement
- Promote automation and emerging technology where intended use, controls, human oversight, and validation expectations are clearly defined
- Ensure lessons learned are incorporated into standards, templates, and future releases
9. Stakeholder Leadership
- Act as the primary GMP Quality authority and escalation point for the ERP program
- Influence decisions across global and site Quality, business, and technology stakeholders without relying solely on direct authority
- Facilitate clear, documented, risk-based decisions and resolve cross-functional quality issues
- Coach process owners, subject matter experts, and project teams on GMP, data integrity, and validation expectations
Skills & Experience
Required
- Bachelor’s degree in science, engineering, information systems, quality, or a related discipline
- Significant experience in pharmaceutical, biotechnology, medical device, or other regulated life sciences environments
- Demonstrated Quality leadership for ERP or large-scale digital transformation programs supporting GMP operations
- Strong knowledge of GMP, computerized system assurance or validation, data integrity, quality risk management, change control, deviation and CAPA processes, and inspection readiness
- Working knowledge of SAP S/4HANA or comparable ERP capabilities and integration across quality, manufacturing, materials, warehouse, and supply chain processes
- Proven ability to make and defend risk-based Quality decisions in a complex global matrix organization
Preferred
- Advanced degree or recognized certification in Quality, auditing, project management, risk management, or computerized system validation
- Experience with SAP S/4HANA transformation, SAP QM, batch management, master data governance, data migration, and regulated integrations
- Experience with global deployments, mergers or divestitures, process harmonization, and multi-site operating models
- Familiarity with process modeling, application lifecycle management, testing, and digital quality tools
Core Capabilities
- GMP Quality leadership and sound independent judgment
- ERP process, data, integration, and control understanding
- Risk-based computerized system assurance and validation
- Data integrity, electronic records, access, and audit trail controls
- Global stakeholder leadership, influence, and conflict resolution
- Clear written and verbal communication with technical and business audiences
- Decision making based on risk, evidence, and measurable outcomes
- Change leadership and sustainable operational adoption
Success Measures (KPIs)
- GMP requirements and critical controls are traceable, verified, and operating effectively
- ERP releases achieve compliant, timely, and sustainable deployment with acceptable residual risk
- Validation effort is proportionate to intended use and risk, with reduced rework and avoidable documentation
- Quality events, defects, audit observations, and recurring control failures decline over time
- Global process adoption, data quality, right-first-time execution, and inspection readiness improve
- Business, Quality, and IT stakeholders demonstrate clear accountability and confidence in Quality decisions
Organizational Relationships
- Reports to: Digital Quality, as defined by the organization
- Provides functional Quality leadership to: ERP workstreams, site Quality representatives, validation resources, and subject matter experts
- Partners with: Global Process Owners, Business Process Leads, IT Architects, SAP Functional Leads, Data and Security Leads, Validation Leads, System Owners, and Manufacturing, Supply Chain, Laboratory, Warehouse, Regulatory, and Finance stakeholders
The salary range for this position is: $243,100.00 - $314,600.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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