Manager, IT Applications

. Responsibilities: -To support Gilead's business by providing project management for the implementation of corporate wide IT system applications relating to GxP (i.e., GMP, GLP and GCP) operations.
-Responsible for coordinating and managing IT application activities among IT operational groups (all Gilead sites), including Global Applications, Global Infrastructure and Information Technology.
-Acting as a focal point of contact to business units for global IT systems that support GxP operations.

Business Areas:
-Keep abreast of ongoing business activities, future business plans as well as FDA/GMP requirements in the Pharmaceutical Development & Manufacturing department.
-Partner with key users and managers in the Pharmaceutical Development & Manufacturing department to ensure project requirements and objectives are effectively communicated to all users.
-Identify risks, devise problem-solving and risk mitigation strategies; coordinate and manage project schedules and deliverables.
-Communicate the project status and major risk items to project team, and facilitate conflict resolution through the complete project lifecycle.
-Partner with IT senior staff, Pharmaceutical Development & Manufacturing department managers to ensure comprehensive development and implementation of project plans and proposals according to the best project management practice.
-Partner with IT staff and Pharmaceutical Development & Manufacturing department to ensure project goals are in line with global business and IT strategic plan.
-Responsible for coordinating effectively and efficiently between business units and IT on projects in the areas of new system evaluation, new application development and system upgrade/migration.
-Responsible for coordinating projects between business units and IT in eQMS maintenance, Smart Solve Product Suite implementation, data migration, change management, Empower, NuGenesis and related validation projects.

Requirements:

-BA/BS degree, preferable in MIS or Life Sciences. 5 years of working experience with a minimum of 2 years of experience in systems analysis and development in Quality Assurance, GMP or regulatory compliance areas, preferable in Pharmaceuticals and Biotechnology industry.
-Broad knowledge of current technologies on IT infrastructure (Network, Citrix, Performance), Computer systems (Windows, Unix), Database (MS SQL, Oracle), Reporting Frameworks (e.g. Crystal reports and software development architecture (MS .NET Framework), and the ability to apply technical knowledge to support the business need. And experiences in Quality Assurance and Pharmaceutical Manufacturing related applications (e.g., LIMS, Document Management, E-records management, Lab Acquisitions Systems ).
-Strong project management and communication skills and the ability to accomplish assigned project objectives according to the approved project plans and coordinate resource requirements to meet the plan objective and schedule.
-Ability to develop statements of work, risk mitigation plans, and lead or participate in developing project plan. Work directly with the business to facilitate the process of defining business and systems requirements.
-Excellent written and verbal communication, strong leadership and coordination skill, highly organized and pays attention to detail.
-Ability to handle multiple tasks simultaneously and effectively with limited oversight.

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