Sr Manager, IT Quality Engineering

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At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description
 

Gilead's mission is to discover, develop and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. As a Sr Manager, IT Quality Engineering you are responsible for working closely with business leads and other IT partner functions to develop and maintain in-depth understanding of business needs and objectives in both business and technology realms. They also stay abreast of dynamics and evolutions in their business and technology areas of assignment to proactively recommend future solutions or other opportunities to the business. IT Quality Engineers support Validation of regulated systems implementations, audits, and inspections.

Specific Responsibilities and Skills

·Oversee multiple complex portfolio of systems and ensures validation activities adhere to quality standards and best practices.

·Manage an area of the overall IT Quality Engineering Program that impacts multiple business areas and/or geographies.

·Strategically manages validation activities across multiple projects/portfolios to ensure alignment with business goals and maximize the efficiency of validation efforts.

·Oversee and provide guidance to other IT Quality Engineers supporting multiple projects.

·Hands on involvement using the Gilead Test management tools, understanding the underlying process and best practices to manage validation artifacts/deliverables.

·As a Validation SME, review and/or approve specifications, protocols, change controls, Corrective and Preventive Actions, deviations to ensure compliance with Gilead procedures and all other applicable regulations.

·Support development and implementation of short- and longer-range strategies, plans, tools and tactics for IT Quality Engineering and compliance at Gilead.

·Demonstrates an understanding of application development methods, the project management process, as well as the fundamentals of requirement specification, design, and development/configuration.

·Supports and maintains the principles and practices of an IT Quality Engineering domain to ensure quality and compliant delivery to business at Gilead.

·Supports development and implementation of the technology and process roadmap for the IT Quality Engineering domain

·Promote a culture of continuous improvement and learning across portfolios.

·Support and work with peers and leads in identifying areas/opportunities and implement changes to enhance Validation process efficiency.

·Evaluates activities and deliverables to ensure results align with Gilead's requirements and metrics needs.

·Manage escalations and participates in the project team as required.

·Monitors metrics to ensure proactive detection of trends and to assess the effectiveness of testing efforts.

·Maintains awareness of industry best-practices and standards.

Basic Qualifications:

8+ Years with Bachelor’s Degree or 6+ Years with Master’s Degree Computer Science or related discipline

Preferred Qualifications:

·Specific experience in the Life Sciences/Pharma/Medical Devices/Healthcare industries.

·Strong knowledge of global regulatory requirements of GMP, GCP, GLP, GDP and/or other domains.

·Strong background and leadership experience in Validation and Infrastructure qualification.

·Significant experience leading Validation on multiple projects, support GxP assess