Senior Manager, Site IT Lead

Описание вакансии

Kite, a Gilead Company, is a biopharmaceutical company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to selectively target and kill cancer cells. Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in this mission!

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Does this sound exciting to you? Join us in our mission!

Senior Manager, Site IT Lead

We are seeking a highly motivated Senior Manager, Site IT Lead to join our growing team in Oceanside, CA.

The Senior Manager, Site IT Lead is responsible for our Kite Viral Vector Manufacturing Site located in Oceanside, CA to support our Cell Therapy strategies and manufacturing business capabilities. This leadership role will partner with our local and global manufacturing teams and respective Tech Ops partners. This will be a critical role within the Kite IT reporting to the Director of MVP01 / TCF03 Site IT Lead. 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

• Lead the Site Technology Council for site technology roadmap and project implementation.
• Partner with Site Operational Technology Lead on the IT strategy, local IT architecture design systems, and IT solutions following overall Global System Architecture, and respective business systems roadmap for the site.
• Partner with Local Site Process/Systems owners, with input from Global COE’s and Kite IT to prioritize local portfolio and align to above roadmap.
• Act as IT Site single point of contact for business systems issues, support, and upgrades.
• Act as single point of contact with Global IT Programs and Global IT and Applications support for site.
• Accountable for local IT budget that rolls up to Cell Therapy IT
• Understand business processes and regulatory environment.
• Accountable and responsible to assess impact of IT Enterprise (Gilead of Kite Global) projects that require implementation at the site.
• Prioritize with site business lead the enterprise IT portfolio and local accountability for these global IT implementations.

Applications

• Lead IT for site specific IT programs partnering with site process, business, and data owners/lead.
• Responsible for the successful implementation and deployment of IT systems
• Coordinate with Site Process Lead and with CoE’s, Cell Therapy IT, and Quality on CSV for plant applications using IQ/PQ protocols.
• Provide IT Hypercare following deployment of plant applications.
• Provide local support and/or first point of contact for Enterprise systems such as ERP, LIMS, PLM, Robar, and G&A applications.
• Partner with 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.
• Provide support to local Quality, Supply Chain, PD IT systems, and integrations with Manufacturing.
• Vendor Management for Managed Services support partners and/or local IT integrators partners
• Provide IT Project Management for local implementations of Global Programs and/or development, configuration, and implementation for local IT projects.
• System Administration for Enterprise applications at the site
• Communicate and facilitate upgrades and updates to Enterprise systems impacting hardware and software.
• Support IT and Systems audits.

Manufacturing Automation and Plant Infrastructure

• Support implementation and deployment of Manufacturing Automation Systems for integration with Enterprise systems.
• Implement plant infrastructure for Plant Application and access by end user devices (e.g., laptops, scanners, barcode readers, printers)
• Implement plant infrastructure to support Manufacturing Automation and connect to plant applications.
• Provide secure connectivity between process control network and Enterprise systems.
• Commission IT rooms, network, and server infrastructure.
• Support of GMP and Non-GMP Network connectivity and servers
• Provide local support for on-site desktop, A/V, Help desk, Lab computers, label printers, handheld mobile devices, scanners, etc.

Operational Leadership

• 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.
• Provide oversight, coaching, and direction for IT staff in region as part of a matrix reporting structure.
• Setup and own a governance process to prioritize business capabilities and technology solutions for site manufacturing.
• Work closely with IT leads in all manufacturing sites to prioritize and implement technology solutions.
• Participate in annual budget cycle with finance, IT, and manufacturing leadership team to submit budget requests for the new technology implementations in the roadmap.
• Lead and develop a team of highly skilled business analysts to deliver business capabilities through technology solutions.
• Understand short term and long-term data analytics and reporting requirements and recommend technology solutions for data warehouse and reporting.

Basic Qualifications:

• PhD and 1+ years of relevant experience OR
• MA/MS in a business or technical discipline and 6+ years of relevant experience OR
• BA/BS in in a business or technical discipline and 8+ years of relevant experience OR
• High School degree and 12+ years of relevant experience

Preferred Qualifications:

• Master’s or bachelor’s degree in engineering, Biology, Chemistry, or Computer/Information Sciences
• MBA or any advanced certification will be a plus.
• 8+ years’ experience in people management, leadership, and developing teams.
• Experience in a GxP manufacturing environment supporting clinical and commercial manufacturing and corresponding technology solutions in a biotech/Pharma industry.
• Experience in Cell Therapy or any other personalized medicine within a “make to order” environment will be preferred.
• Six Sigma Black Belt or similar qualification will be a plus.
• Thorough understanding of various project management methodologies to be accountable for large project implementations
• Excellent interpersonal, verbal, and written communication skills
• Excellent presentation skills and ability to interact and interface with all levels of business including senior leadership team.
• Experience in implementing and leading change management and governance process, as well as owning deviations and change control in a regulated environment.
• Effective organization and time management skills, with the ability to work under pressure and adhere to project deadlines in a dynamic environment.
• Proficient in resources like PowerPoint and Visio to develop process flows and presentations.