Gilead Sciences - Foster City, CA

posted 3 months ago

Full-time - Manager
Foster City, CA
Chemical Manufacturing

About the position

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 fulfill their aspirations. Join Gilead and help create possible, together. 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 an in-depth understanding of business needs and objectives in both business and technology realms. You will stay abreast of dynamics and evolutions in your 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. You will oversee a complex portfolio of systems and ensure validation activities adhere to quality standards and best practices. This role involves managing an area of the overall IT Quality Engineering Program that impacts multiple business areas and/or geographies, strategically managing validation activities across multiple projects/portfolios to ensure alignment with business goals and maximize the efficiency of validation efforts. You will also oversee and provide guidance to other IT Quality Engineers supporting multiple projects, and be hands-on involved using Gilead Test management tools, understanding the underlying process and best practices to manage validation artifacts/deliverables. As a Validation SME, you will review and/or approve specifications, protocols, change controls, and Corrective and Preventive Actions to ensure compliance with Gilead procedures and all other applicable regulations. Additionally, you will support the development and implementation of short- and longer-range strategies, plans, tools, and tactics for IT Quality Engineering and compliance at Gilead.

Responsibilities

  • Oversee multiple complex portfolio of systems and ensure 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 manage 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.
  • Demonstrate an understanding of application development methods, the project management process, as well as the fundamentals of requirement specification, design, and development/configuration.
  • Support and maintain the principles and practices of an IT Quality Engineering domain to ensure quality and compliant delivery to business at Gilead.
  • Support 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.
  • Evaluate activities and deliverables to ensure results align with Gilead's requirements and metrics needs.
  • Manage escalations and participate in the project team as required.
  • Monitor metrics to ensure proactive detection of trends and to assess the effectiveness of testing efforts.
  • Maintain awareness of industry best practices and standards.

Requirements

  • 8+ Years with Bachelor's Degree or 6+ Years with Master's Degree in Computer Science or related discipline.
  • 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, supporting GxP assessments, estimating schedules, resources, tasks, managing escalations and dependencies.
  • Experience validating ERP, Supply chain, LIMS, Manufacturing, Salesforce, Veeva, Patient Safety applications is a plus.
  • Broad knowledge on AWS and Azure Cloud standards and experience validating cloud-based systems.
  • Strong experience in managing complex Data Migration projects, supporting development of data migration plans and strategy.
  • Hands-on experience with testing and validating Data Analytics platforms, Data Cloud, Data Lakes, Data pipelines and data testing.
  • Strong experience in validation of end-to-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 software testing standards in SDLC.
  • Strong collaboration skills required to effectively work across a diverse group including executives, 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 and global site and functional area employees to a successful project outcome.
  • Objective and transparent with data and information.
  • Ability to provide clear perspective and rationale for thinking and functioning successfully in a dynamic environment.
  • Strong experience in troubleshooting complex systems/applications quality and compliance issues and recommending appropriate remediations.
  • Significant experience identifying and recommending updated or new IT quality and compliance standards, processes and tools.
  • Significant experience supporting IT integrations and transformations in a corporate or other relevant business environment.
  • Significant 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 desired 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 HP ALM, Jira and Azure DevOps.

Nice-to-haves

  • Experience validating ERP, Supply chain, LIMS, Manufacturing, Salesforce, Veeva, Patient Safety applications is a plus.
  • Broad knowledge on AWS and Azure Cloud standards and experience validating cloud-based systems.

Benefits

  • Company-sponsored medical, dental, vision, and life insurance plans.
  • Discretionary annual bonus.
  • Discretionary stock-based long-term incentives (eligibility may vary based on role).
  • Paid time off.
© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service