Sr Director, ERP GMP Quality Lead

Gilead Sciences•Foster City, CA

14d

About The Position

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 Quality business processes. The role ensures ERP processes and controls are fit for intended use, compliant, appropriately standardized, 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, 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, and interfaces with laboratory, regulatory, and other GxP systems. The ERP GMP Quality Lead serves as the primary GMP Quality authority and escalation point for the ERP program, influencing global and site stakeholders and guiding documented, risk-based decisions. The position provides oversight throughout process design, deployment, stabilization, and ongoing operation; supports validation and release readiness; and establishes governance and performance monitoring to sustain compliant operations and continuous improvement. It reports to Digital Quality, as defined by the organization, and provides functional Quality leadership to ERP workstreams, site Quality representatives, validation resources, and subject matter experts.

Requirements

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.
GMP Quality leadership and sound independent judgment.
Understanding of ERP processes, data, integrations, and controls.
Risk-based computerized system assurance and validation knowledge.
Understanding of data integrity, electronic records, access, and audit trail controls.
Global stakeholder leadership, influence, and conflict resolution skills.
Clear written and verbal communication with technical and business audiences.
Ability to make decisions based on risk, evidence, and measurable outcomes.
Change leadership and sustainable operational adoption capabilities.

Nice To Haves

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.

Responsibilities

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.
Guide global process owners and design teams in defining standardized, compliant, 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 handled through governed exceptions; maintain GMP Quality design principles, critical controls, acceptance criteria, and decision records.
Develop and maintain connections to industry groups on GMP topics in ERP; evaluate industry solutions and relay industry feedback to software suppliers.
Partner with software suppliers and vendors to promote product roadmaps aligned with Gilead’s strategic ERP GMP goals; identify and evaluate GMP ERP platforms, tools, and solutions.
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.
Own and approve business requirements for Quality processes; confirm 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.
Ensure ERP deployments meet 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 post-go-live changes remain controlled through the system lifecycle.
Establish and maintain Quality governance for ERP design decisions, risks, exceptions, releases, and lifecycle changes.
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.
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 when intended use, controls, human oversight, and validation expectations are clearly defined.
Incorporate lessons learned into standards, templates, and future releases.
Act as the primary GMP Quality authority and escalation point for the ERP program; influence global and site Quality, business, and technology stakeholders.
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.