Sr Director, ERP GMP Quality Lead

Key Responsibilities

• 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
• 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
• 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.
• 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
• 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
• 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
• 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
• 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
• 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.

For jobs in the United States:

For Current Gilead Employees and Contractors:

Qualifications

• 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
• 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
• 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.
• 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 disability, genetic 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 laws. In 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 [email protected] for assistance.
• For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
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• YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
• Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
• Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
• Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
• Please apply via the Internal Career Opportunities portal in Workday.

Preferred Qualifications

• Preferred
• 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.