IT Quality Engineering Manager - Validation & Compliance Leader

Regulatory Jobs; Foster City (CA); On-site; USD 136,000 - 176,000; Full time

Job summary

Gilead Sciences Inc. is seeking a Quality Engineering Manager to lead validation activities across multiple programs and geographies in Foster City, CA.

The role focuses on ensuring compliance with GMP, GCP, GLP, and related standards while aligning with business objectives. The candidate will oversee a portfolio of regulated systems, review validation artifacts, and drive continuous improvement in validation processes and tools.

Qualifications

• Ability to oversee complex portfolio of systems and ensure validation activities adhere to quality standards.
• Manage an area of IT Quality Engineering Program that spans multiple geographies.
• Lead validation across multiple projects and support GxP assessments and inspections.
• Provide guidance to IT Quality Engineers on validation artifacts and deliverables.
• Review specifications, protocols, change controls, CAPAs and deviations for compliance.

Responsibilities

• Oversee validation activities to ensure compliance with quality standards.
• Lead cross-functional IT Quality Engineering initiatives across geographies.
• Coordinate validation efforts across projects, including AI initiatives.
• Mentor and guide other IT Quality Engineers on validation artifacts.
• Review and approve validation documentation to meet regulatory requirements.

Skills

IT Quality Engineering

Validation

QA Testing

Regulatory Compliance

Education

Bachelor’s Degree in CS

Master’s Degree

Tools

Microfocus ALM

Jira

Azure DevOps

SAP ERP

Job description

Gilead Sciences Inc. is seeking a Quality Engineering Manager to lead validation activities across multiple programs and geographies in Foster City, CA.

The role focuses on ensuring compliance with GMP, GCP, GLP, and related standards while aligning with business objectives. The candidate will oversee a portfolio of regulated systems, review validation artifacts, and drive continuous improvement in validation processes and tools.