Senior Director, ERP GMP Quality Lead

Gilead Sciences

. Provide quality leadership and independent GMP oversight for the design, deployment, and operation of ERP solutions supporting regulated Quality business processes .

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 oversight and Quality leadership for ERP solutions, ensuring compliance and operational effectiveness across regulated processes. Proficient in risk-based decision-making and stakeholder collaboration within complex global environments.

Highest-signal resume keywords

GMP Quality LeadershipSAP S/4HANA ExperienceQuality Risk ManagementData Integrity AssuranceChange Control Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

GMP OversightQuality Risk ManagementData IntegrityChange ControlValidation ProcessesERP Process DesignProcess ModelingDigital Quality ToolsBatch ManagementMaster Data Governance

Soft Skills

Clear CommunicationConflict ResolutionDecision MakingLeadershipCoaching

Tools & Technologies

SAP S/4HANAComputerized System ValidationQuality Management SystemsApplication Lifecycle ManagementDigital Transformation Tools

Certifications & Qualifications

Advanced Degree in QualityProject Management CertificationRisk Management CertificationAuditing Certification

Industry Keywords

PharmaceuticalBiotechnologyMedical DeviceRegulated Life SciencesInspection Readiness

Tech Stack

Tools & technologies

ERP

About the role

Key responsibilities & impact

Provide quality leadership and independent GMP oversight for the design, deployment, and operation of ERP solutions supporting regulated Quality business processes
Serve as the Quality lead for ERP program decisions affecting GMP processes, data, records, controls, and regulated operations
Provide 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
Partner with software suppliers and vendors on ERP GMP capabilities and product roadmaps
Partner with Quality, Business, IT, Data, Security, Validation, and site Quality stakeholders
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 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
Act as the primary GMP Quality authority and escalation point for the ERP program
Coach process owners, subject matter experts, and project teams on GMP, data integrity, and validation expectations

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
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical insurance
Company-sponsored dental insurance
Company-sponsored vision insurance
Company-sponsored life insurance