Manager, IT Quality Engineering

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
 

The Quality Engineering, Manager work 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 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 including AI initiatives 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 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:

• 6+ Years of experience with Bachelor’s Degree
• 4+ Years of experience with Master’s Degree
• Computer Science or related discipline is preferred

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 Management experience in Validation.
• Significant experience leading Validation on multiple projects, support GxP assessments, estimating schedules, resources, tasks, manage escalations and dependencies.
• Experience validating SAP ERP, Supply chain, LIMS, Manufacturing, Salesforce, Veeva, Patient Safety applications is a plus.
• Hands on experience with Managing Requirements and Test artifacts in Requirement and Test Management Tools like Application Lifecycle Management (ALM)
• Strong experience in managing complex Data Migration projects, support development of data migration plans and strategy.
• Strong experience in validation of end-end integrations built with various integration solutions.  
• Strong experience in managing change controls, CAPAs and Deviations.  
• Strong experience with Managed Service Operations.
• Hands on experience in software quality assurance and ability to emphasize and influence the stakeholders to apply software testing standards in SDLC.
• Strong collaboration skills required to effectively work across a diverse group including leaders, managers and subject matter experts (SME).
• Knowledge and experience with CSA.
• Ability to track and follow up on actions requiring the team’s completion.
• Ability to lead and influence a cross-functional team, global site and functional area employees to a successful project outcome.
• Ability to provide clear perspective and rationale for thinking and functioning successfully in a dynamic environment.
• Strong experience in trouble-shooting complex systems/ applications quality and compliance issues and recommending appropriate remediations.
• Significant experience supporting IT integrations and transformations in a corporate or other relevant business environment.
• Experience supporting IT quality and compliance audits and inspections.
• Significant experience managing IT consultants and vendors.
• Coaching and collaboration skills to interact with all levels of personnel to achieve shared goals.
• Ability to develop and maintain effective relationships with internal and external stakeholders.
• Must be able 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 the development and test management tools, including experience with Microfocus ALM, Jira and Azure DevOps.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [email protected] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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