Sr Director, ERP GMP Quality Lead
Gilead Sciences Inc.
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Benefits offered by this job
Job summary
Gilead Sciences Inc. is seeking a Sr. Director, ERP GMP Quality Lead to provide quality leadership for ERP programs across GMP processes and data integrity.
The role partners with Quality, IT, Validation, and business stakeholders to enable compliant, scalable ERP implementations and ongoing operation. The role covers GMP ERP capabilities including quality planning, batch release support, material and supplier quality, and regulated master data.
Qualifications
- Bachelor’s degree and significant experience in regulated life sciences environments.
- Quality leadership for ERP or large-scale digital transformation programs.
- Strong knowledge of GMP, validation, data integrity, risk management, change control and inspection readiness.
Responsibilities
- Provide GMP Quality leadership for ERP program decisions affecting GMP processes and records.
- Guide global teams to define standardized, compliant ERP processes with proper controls.
- Collaborate with industry groups and vendors to align ERP roadmaps with GMP goals.
- Ensure GMP controls operate across Manufacturing, Supply Chain, and related functions.
- Own and approve validation readiness, changes, and deployment readiness.
Skills
Education
Tools
Job description
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.
- 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
- 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
- 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
- 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
- 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:
Bay Area: $243,100.00 - $314,600.00.
Other US Locations: $221,000.00 - $286,000.00.
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: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 ApplicantAccommodations@gilead.com for assistance.For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
Gilead Sciences will not disclose 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.
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