Sr Director, ERP GMP Quality Lead

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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 Gileads strategic EPP GMP goals.
• Identify and evaluate GMP ERP platforms tools and solutions to build novel ways of meeting Gileads 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

• Bachelors 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: $243100.00 - $314600.00. 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:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic information or characteristic gender identity and expression veteran status or other non-job related characteristics or other prohibited grounds specified in applicable federal state and local order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973 the Vietnam Era Veterans Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990 applicants who require accommodation in the job application process may contact for assistance.

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