Manager, IT Quality Engineering

Gilead Sciences • Foster City, CA

11d • $136,340 - $176,440

About The Position

The Manager, IT Quality Engineering works closely with business leads and IT partner functions to understand business and technology needs, stay current with changes in assigned areas, and recommend future solutions. The role supports validation of regulated system implementations, audits, and inspections.

The manager oversees a complex portfolio of systems and validation activities across projects, business areas, and geographies, including AI initiatives. They guide other IT Quality Engineers, contribute hands-on expertise with Gilead test management tools, and serve as a validation subject matter expert reviewing or approving specifications, protocols, change controls, Corrective and Preventive Actions (CAPAs), and deviations. The role also supports IT Quality Engineering strategy, compliance, technology and process roadmaps, continuous improvement, metrics monitoring, escalations, and project delivery.

Requirements

• At least 6 years of experience with a bachelor's degree, or at least 4 years with a master's degree.
• Strong knowledge of global regulatory requirements such as GMP, GCP, GLP, GDP, or other applicable domains.
• Strong background and management experience in validation.
• Experience leading validation across multiple projects, supporting GxP assessments, estimating schedules and resources, managing tasks, escalations, and dependencies.
• Hands-on experience managing requirements and test artifacts in requirements and test management tools.
• Experience managing complex data migration projects and supporting data migration plans and strategy.
• Experience validating end-to-end integrations built with various integration solutions.
• Experience managing change controls, CAPAs, and deviations.
• Experience with managed service operations.
• Hands-on software quality assurance experience and ability to influence stakeholders to apply software testing standards in the SDLC.
• Strong collaboration skills working across leaders, managers, and subject matter experts.
• Knowledge and experience with CSA.
• Ability to track and follow up on team actions.
• Ability to provide a clear perspective and rationale and work successfully in a dynamic environment.
• Experience troubleshooting complex system or application quality and compliance issues and recommending remediation.
• Experience supporting IT integrations and transformations in a corporate or relevant business environment.
• Experience supporting IT quality and compliance audits and inspections.
• Experience managing IT consultants and vendors.
• Coaching and collaboration skills to work with personnel at all levels.
• Ability to develop and maintain effective internal and external stakeholder relationships.
• Ability to lead and influence onshore and offshore development and validation teams.
• Knowledge and experience with CI/CD deployment methods, source code management, and DevOps tools.
• Working knowledge of Waterfall, Scrum, DevOps, and Agile methodologies.
• Broad understanding of development and test management tools, including Micro Focus ALM, Jira, and Azure DevOps.

Nice To Haves

• Computer Science or a related discipline.
• Experience in the life sciences, pharmaceutical, medical device, or healthcare industries.
• Experience validating SAP ERP, supply chain, LIMS, manufacturing, Salesforce, Veeva, or patient safety applications.
• Experience with Application Lifecycle Management (ALM) and other requirements and test management tools.

Responsibilities

• Oversee a complex portfolio of systems and ensure validation activities follow quality standards and best practices.
• Manage an area of the IT Quality Engineering Program that impacts multiple business areas or geographies.
• Strategically manage validation activities across multiple projects and portfolios, including AI initiatives, to align with business goals and improve efficiency.
• Oversee and guide IT Quality Engineers supporting multiple projects.
• Use Gilead test management tools and apply the underlying processes and best practices for validation artifacts and deliverables.
• Review and/or approve specifications, protocols, change controls, CAPAs, and deviations as a Validation SME to ensure compliance with Gilead procedures and applicable regulations.
• Support short- and long-range strategies, plans, tools, and tactics for IT Quality Engineering and compliance.
• Support and maintain IT Quality Engineering principles and practices to ensure quality and compliant delivery.
• Support development and implementation of the IT Quality Engineering technology and process roadmap.
• Promote continuous improvement and learning across portfolios.
• Identify opportunities with peers and leads and implement changes to improve validation process efficiency.
• Evaluate activities and deliverables to ensure alignment with Gilead requirements and metrics needs.
• Manage escalations and participate in project teams as required.
• Monitor metrics to detect trends proactively and assess testing effectiveness.
• Maintain awareness of industry best practices and standards.
• Lead and influence cross-functional, global, onshore, and offshore teams toward successful project outcomes.
• Support IT quality and compliance audits and inspections, IT integrations, and transformations.

Benefits

• The position may be eligible for a discretionary annual bonus.
• The position may be eligible for discretionary stock-based long-term incentives; eligibility may vary by role.
• Paid time off.
• Company-sponsored medical insurance.
• Company-sponsored dental insurance.
• Company-sponsored vision insurance.
• Company-sponsored life insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager