Senior Director, ERP GMP Quality Lead

Gilead Sciences

. Serve as the Quality lead for ERP program decisions affecting GMP processes, data, records, controls, and regulated operations .

Posted 10/28/2026full-timeFoster City • California • United StatesSenior💰 $243,100 - $314,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in GMP Quality leadership, risk-based decision making, and compliance oversight for ERP programs in regulated environments. Proficient in managing quality processes, data integrity, and validation across global operations.

Highest-signal resume keywords

GMP Quality LeadershipSAP S/4HANA ExperienceRisk-Based Quality Decision MakingChange Control and ValidationGlobal Stakeholder Influence

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Risk ManagementData IntegrityComputerized System ValidationChange ControlDeviation and CAPA ProcessesProcess ModelingApplication Lifecycle ManagementTestingGMP ComplianceQuality KPIs Monitoring

Soft Skills

Clear CommunicationConflict ResolutionDecision MakingCoachingLeadership

Tools & Technologies

SAP S/4HANADigital Quality ToolsERP SystemsData Migration ToolsBatch Management

Certifications & Qualifications

Advanced Degree in QualityCertification in AuditingProject Management CertificationRisk Management CertificationComputerized System Validation Certification

Industry Keywords

PharmaceuticalBiotechnologyMedical DeviceRegulated Life SciencesGMP Processes

Tech Stack

Tools & technologies

Cyber SecurityERP

About the role

Key responsibilities & impact

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
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
Develop and maintain connection to industry groups and partner with software suppliers and vendors on GMP ERP solutions and product roadmaps
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
Own and approve business requirements for Quality processes
Confirm critical requirements and controls are verified with objective evidence and resolve or accept defects and residual risks
Approve GMP readiness for releases, deployments, major changes, and transition to operations
Ensure ERP deployments comply with change control, validation, data migration, cutover, training, and procedural readiness requirements
Support go-live decisions, hypercare, issue triage, and transition to validated operations
Establish and maintain Quality governance for ERP design decisions, risks, exceptions, releases, and lifecycle changes
Support inspection readiness, regulatory inspections, internal audits, and related responses
Drive investigation and remediation of quality events, control failures, and audit observations
Define and monitor Quality and compliance KPIs and use trends and risk signals to prioritize corrective actions
Promote automation and emerging technology where intended use, controls, human oversight, and validation expectations are defined
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
Coach process owners, subject matter experts, and project teams on GMP, data integrity, and validation expectations
Report to Digital Quality and provide functional Quality leadership to ERP workstreams, site Quality representatives, validation resources, and subject matter experts

Requirements

What you’ll need

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 preferred
Experience with SAP S/4HANA transformation, SAP QM, batch management, master data governance, data migration, and regulated integrations preferred
Experience with global deployments, mergers or divestitures, process harmonization, and multi-site operating models preferred
Familiarity with process modeling, application lifecycle management, testing, and digital quality tools preferred
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

Benefits

Comp & perks

Discretionary annual bonus eligibility
Discretionary stock-based long-term incentives eligibility may vary based on role
Paid time off
Company-sponsored medical insurance
Company-sponsored dental insurance
Company-sponsored vision insurance
Company-sponsored life insurance
Reasonable accommodation during the job application process