Manager, IT Quality Engineering

What you'll do

• Oversee a complex portfolio of systems to ensure validation activities adhere to quality standards and best practices.
• Manage an IT Quality Engineering program that impacts multiple business areas and global geographies.
• Strategically manage validation activities across multiple projects and AI initiatives to align with business goals.
• Review and approve specifications, protocols, change controls, CAPAs, and deviations to ensure regulatory compliance.
• Use Gilead test management tools to manage validation artifacts and deliverables.
• Support the development and implementation of the technology and process roadmap for the IT Quality Engineering domain.
• Monitor metrics to proactively detect trends and assess the effectiveness of testing efforts.
• Manage IT consultants and vendors while leading onshore and offshore development and validation teams.

What we're looking for

• 6+ years of experience with a Bachelor’s Degree.
• Master’s Degree in Computer Science or a related discipline (preferred).
• Specific experience in the Life Sciences, Pharma, Medical Devices, or Healthcare industries (preferred).
• Strong knowledge of global regulatory requirements including GMP, GCP, GLP, and GDP (preferred).
• Strong background and management experience in Validation (preferred).
• Significant experience leading Validation on multiple projects, supporting GxP assessments, and managing escalations (preferred).
• Experience validating systems such as SAP ERP, LIMS, Salesforce, or Veeva (preferred).
• Working knowledge of Waterfall, Scrum, DevOps, and Agile methodologies (preferred).