Manager, IT Quality Engineering

Gilead Sciences • Foster City, CA

9d

About The Position

The Quality Engineering Manager works closely with business leads and IT partner functions to understand business and technology needs, stay informed about changes in assigned areas, and recommend future solutions. IT Quality Engineers support validation of regulated system implementations, audits, and inspections. The manager oversees a complex portfolio of systems and validation activities, including work across multiple projects, business areas, and geographies, and helps ensure compliance with quality standards, Gilead procedures, and applicable regulations.

The role provides guidance to IT Quality Engineers and serves as a validation subject-matter expert, reviewing or approving validation deliverables and supporting quality and compliance strategies, tools, processes, and roadmaps. It promotes continuous improvement and learning, monitors testing metrics, manages escalations, and collaborates with internal and external stakeholders to deliver compliant business solutions.

Requirements

• At least 6 years of experience with a bachelor's degree, or at least 4 years of experience with a master's degree.
• Computer Science or a related discipline is preferred.
• Strong knowledge of global regulatory requirements, including GMP, GCP, GLP, GDP, and/or other domains.
• Strong background and management experience in validation.
• Significant experience leading validation on multiple projects, supporting GxP assessments, estimating schedules, resources, and tasks, and managing escalations and dependencies.
• Hands-on experience managing requirements and test artifacts in requirements and test management tools.
• Strong experience managing complex data migration projects and supporting development of data migration plans and strategy.
• Strong experience validating end-to-end integrations built with various integration solutions.
• Strong experience managing change controls, CAPAs, and deviations.
• Strong 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 to work effectively with leaders, managers, and subject-matter experts.
• Ability to track and follow up on team actions.
• Ability to lead and influence cross-functional teams, global site employees, and functional-area employees toward successful project outcomes.
• Ability to provide a clear perspective and rationale and function successfully in a dynamic environment.
• Significant experience supporting IT integrations and transformations in a corporate or other relevant business environment.
• Coaching and collaboration skills to work with personnel at all levels toward shared goals.
• Ability to develop and maintain effective relationships with internal and external stakeholders.
• 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 experience with Micro Focus ALM, Jira, and Azure DevOps.

Nice To Haves

• 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.
• Knowledge and experience with CSA.

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 affecting multiple business areas and/or geographies.
• Strategically manage validation activities across multiple projects and portfolios, including AI initiatives, to align with business goals and improve validation efficiency.
• Oversee and guide IT Quality Engineers supporting multiple projects.
• Use Gilead test management tools and apply knowledge of the underlying processes and best practices for validation artifacts and deliverables.
• As a validation subject-matter expert, review and/or approve specifications, protocols, change controls, Corrective and Preventive Actions (CAPAs), and deviations for 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 domain principles and practices for quality and compliant delivery.
• Support development and implementation of the technology and process roadmap for the IT Quality Engineering domain.
• Promote continuous improvement and learning across portfolios, identifying and implementing opportunities to improve validation process efficiency with peers and leads.
• Evaluate activities and deliverables to ensure they align with Gilead requirements and metrics needs.
• Manage escalations and participate in project teams as needed.
• Monitor metrics to detect trends proactively and assess testing effectiveness.
• Maintain awareness of industry best practices and standards.
• Track and follow up on actions requiring team completion.
• Troubleshoot complex system and application quality or compliance issues and recommend remediations.
• Support IT quality and compliance audits and inspections.
• Manage IT consultants and vendors.
• Lead and influence onshore and offshore development and validation teams and cross-functional teams toward successful project outcomes.

Benefits

• May be eligible for a discretionary annual bonus.
• 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