Sr Manager, RDMC IT Lead

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

We are seeking a highly motivated Sr. Manager, Site IT Lead (RDMC) to join our team based in Santa Monica, CA .

The Site IT Lead is responsible for our Kite Research & Development Manufacturing Site supporting our Cell Therapy strategies and manufacturing business capabilities. This leadership role will partner with our local and global manufacturing, PD and R&D teams and respective Tech Ops partners. This will be a critical role within the Kite IT reporting to the Executive Director of Technical Operations and KK Enterprise IT. It is a highly cross functional role working closely with the leadership team from various business groups, Gilead and Kite IT.

Responsibilities of the Senior Manager Site IT Lead include, but are not limited to:

Strategy and Roadmap

1. Facilitate the Site Technology Council for site technology roadmap and project implementation.
2. Partner with Global IT, Site Operational Technology Lead and PD IT on implementing IT strategy, local IT architecture design of systems, and IT solutions following overall Global System Architecture, and respective business systems roadmap for the site.
3. Partner with Local Site Process/Systems owners, with input from Global COE’s and Global IT to prioritize local portfolio and align to above roadmap.
4. Provide as point of contact for business systems issues, support, and upgrades.
5. Understand business processes and regulatory environment.
6. Accountable to assess impact of IT Enterprise (either Gilead or Kite Global) projects that require implementation at the site.
7. Prioritize with site business lead on enterprise IT portfolio and local accountability for these global IT implementations with Global IT support functions.

Applications

1. Facilitate site specific IT programs partnering with site process, business, and data owners/lead.
2. Facilitate implementation and deployment of IT systems.
3. Coordinate with Site Process Lead and with CoE’s, Cell Therapy IT, and Quality on CSV for plant applications in supporting of IQ/PQ protocols.
4. Provide IT Hypercare with Global IT functional team following deployment of plant applications.
5. Partner with global functional team to support and/or be the first point of contact for enterprise systems such as ERP, LIMS, PLM, Robar, and G&A applications.
6. Partner with global functional team and local Operations lead on supporting plant applications like MES/EBR and BMS with super user and system administration training for each release; provide basic maintenance configuration under guidance of Site Process owner.
7. Provide support to local Quality, Supply Chain, PD IT systems, and integrations with Manufacturing.
8. Provide vendor management for Managed Services support partners and/or local IT integrators partners.
9. Provide support in IT Project Management for local implementations of Global Programs and/or development, configuration, and implementation for local IT projects.
10. Work with global IT functions in providing System Administration for enterprise applications at the site.
11. Coordinate support in communicating and facilitate upgrades and updates to enterprise systems impacting hardware and software.
12. Support IT and Systems audits with global functional teams.

Manufacturing Automation and Plant Infrastructure

1. Support implementation and deployment of Manufacturing Automation Systems for integration with Enterprise systems.
2. Support the implementation of plant infrastructure for Plant Application and access by end user devices (e.g., computers, scanners, barcode readers, printers).
3. Support implementation of plant infrastructure to support of Manufacturing Automation and connect to plant applications.
4. Support commissioning of IT rooms, network, and server infrastructure.
5. Support of GMP and Non-GMP Network connectivity and servers.

Operational Leadership

1. Act as key business partner to the global and regional heads of department to ensure platforms, processes, and operation models are fit for purpose and providing escalation and information to the global team on areas.
2. Provide oversight, coaching, and direction for IT staff in region as part of a matrix reporting structure.
3. Setup and own a governance process to prioritize business capabilities and technology solutions for site manufacturing.
4. Work closely with IT leads in all manufacturing sites to prioritize and implement technology solutions.
5. Participate in annual budget cycle with finance, IT, and manufacturing leadership team to submit budget requests for the new technology implementations in the roadmap.
6. Lead and manage a team of highly skilled business analysts to deliver business capabilities through technology solutions.
7. Understand short term and long-term data analytics and reporting requirements and recommend technology solutions for data warehouse and reporting.

Basic Qualifications:

1. MA/MS in a business or technical discipline and 6+ years of relevant experience OR
2. BA/BS in a business or technical discipline and 10+ years of relevant experience OR
3. High School degree and 15+ years of relevant experience.

Preferred Qualifications:

1. Masters or Bachelor’s degree in Engineering, Biology, Chemistry, or Computer/Information Sciences.
2. 8+ years of strong people management, leadership, and team development skills.
3. Experience in a GxP manufacturing environment supporting clinical and commercial manufacturing and corresponding technology solutions in a biotech/Pharma industry.
4. Experience in Cell Therapy or any other personalized medicine within a “make to order” environment will be preferred.
5. Six Sigma Black Belt or similar qualification will be a plus.
6. Solid understanding of various project management methodologies to be accountable for large project implementations.
7. Excellent interpersonal, verbal, and written communication skills.
8. Excellent presentation skills and ability to interact and interface with all levels of business including senior leadership team.
9. Experience in implementing and leading change management and governance process, as well as owning deviations and change control in a regulated environment.
10. Effective organization and time management skills, with the ability to work under pressure and adhere to project deadlines in a fast-paced environment.
11. Proficient in tools like PowerPoint, Visio, and other tools to develop process flows and presentations.