Sr Manager, Serialization Compliance; Manufacturing

Sr Manager, Serialization Compliance (Manufacturing) Job Description

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.

This role will represent the business on cross‑functional teams delivering several projects in Gilead’s Commercial Manufacturing Organization. In this role, the individual will be responsible for ensuring initiatives and projects meet the core business requirements and impacted business processes are updated for internal manufacturing and serialization & traceability. These global business processes are applicable or used by internal sites, business functions, Commercial Manufacturing Organizations (CMOs), third‑party logistics (3PLs) providers, and alliance partners.

• Supports business analysis for changes and new initiatives within the commercial manufacturing organization for internal manufacturing and global serialization & traceability enterprise systems
• Responsible for documenting the as‑is business processes and systems
• Responsible for completion of high‑level requirements gathering, use case development, and documentation of user requirements
• Responsible for completion of business process re‑engineering and change impact assessments
• Manage the completion of system regression testing as required by Gilead’s IT validation processes
• Planning, coordinating and execution of User Acceptance Testing of new and upgraded system solutions and the associated impacted business processes
• Collaborates with Gilead’s global functional groups and supports the interpretation of both emerging and changing global serialization & traceability regulations and industry standards (e.g. GS1)
• Determine impacts of these possible changes to Gilead systems and business processes and implementing solutions to support the new and changing regulatory and business requirements
• Manage assigned global cross‑functional strategies and activities associated with the implementation and management of activities for all commercial products across all manufacturing sites including all contract manufacturing organizations (CMOs)
• Lead and perform strategic assessments based on business needs and requirements
• Perform business process and enterprise systems assessments with IT and other business functions based
• Develop solution options and cost analysis to meet business requirements
• Develop and present results of strategic analysis to leadership
• Represent Gilead’s Global Serialization & Traceability function on global cross‑functional teams and initiatives. Deliver robust system solutions to support Gilead’s serialization & traceability related business processes (current or future)
• Works on problems of moderate to advanced complexity where analysis of situations or data requires an evaluation of intangible variables
• Provides oversight, guidance and management of personnel working on assigned projects and operational support processes
• Creates and maintains a positive working environment to ensure high productivity, employee engagement and performance
• Exercises independent judgment in developing methods, techniques, and evaluation criteria for…