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IT Delivery Lead R&D
4 months ago
**IT Delivery Lead R&D**
United States - North Carolina - Raleigh Information Technology Regular * Participates in business customer idea elaboration and technical problem-solving with potential technical options including proposals, front-end studies, development plans, and presentations
* Partner with capability manager and global capability lead and Portfolio lead to create the business case and Deliver the Projects to support Business strategy.
* Partner with the capability manager to capture, analyze and document functional requirements specifications from high level business requirements
* Defines technical strategies by performing evaluations, proof of concepts and assessments on the various technical aspects of the proposed project solution
* Accountable for working with Business Process Owner, IT Compliance (for non-GxP systems) or QA (for validated systems) to identify the appropriate System Life Cycle model based on applicable regulatory requirements before presenting estimates for input to new system business case or change implementation plans
* Participates in the creation of Request for Proposals (RFP) from a technical perspective.
* Partner with Implementation Vendor to ensure the effective execution of the projects and services, holding them accountable to project scope, SLAs and KPIs.
* Partners with Project Managers (PMs) to develop the technical delivery work plan and schedule and ensures that appropriate technical delivery staffing resources are assigned, and effectively utilized. Works with the Project Manager, BPO, IT Compliance (for non-GxP systems) or Validation Lead (for validated systems or qualified infrastructure) to ensure that the project plan reflects the dependencies and required deliverables of the selected System Life Cycle model
* Leads or assists with scoping, identification of project deliverables, project time estimations, resource level estimations and ensure that the creation of project-specific documentation such as technical specifications are produced
* Provide Support for technical implementation activities during functional requirements and design, cost and timeline estimation, and assist in the management and communication to Gileads stakeholders.
* Owns the delivery of the overall technical workstream or one or more technical modules of the project under development by leading and managing the technical delivery team Understands the end-to-end technical architecture for the solution being developed. Acts as a point of contact for technical escalation and resolution during the project lifecycle as it relates to technical decisions
* Work as the primary technical and delivery lead for Safety and, Medical Affairs
* Determines and provides the necessary level of technical documentation during requirements gathering, based on technical services standards and procedures and discussions with the project team and technical vendors
* Create/update and review system related documents including validation deliverables
* Communicates proactively with the Project Manager and project team regarding project status
* Ensures formal technical and performance reviews are conducted and provides feedback and suggestions
* Ensures that training design documentation and delivery from a technical perspective are in place
* Ensures that project knowledge transfer occurs between project engineers and operational support staff
* Facilitates creation of control for all non-GxP and GxP change requests to meet compliance requirements
* Partners with external business partners to meet the technical project needs as appropriate
* Works with the project software vendor(s) technical teams to ensure adequate solution design
* Facilitates and coordinates technical guidance to IT senior staff, working closely with solution architects and engineers
* Ensures that technical delivery is in compliance with architecture and technical standards
* Serves as an advocate and endorses and enforces technological best practices in collaboration with solution architects
* Develops, documents and shares technical delivery best practices.
* Partners with Quality Assurance (QA), IT Compliance and Validation resources to consult and review test plans and validation plans and ensure that issues are properly assigned, fixed, and regressed
* Support Validation/QA teams on ensuring GxP compliance of Safety and Medical Affairs systems with the corporate standard for IT change management and IT SOPs following 21 CFR Part 11 and Annex 11 requirements.
* Provide technical guidance to local support team as well as work with Managed Services partner for sustainment related activities
* On-site escalation point for technical issues related to Safety and Medical Affairs areas
* Consultative role on technical support areas, working closely with the System Manager
* Provide technical guidance to local support team as well as work with Managed Services partner for sustainment related activities
* Laser-focused and strong delivery experience managing large, complex projects.
* Must think ahead strategically and must be able to weigh and decide between implementing new functionality by configuration of existing technology vs assessment of new technology.
* Has a strong working understanding of installed systems, with the ability to troubleshoot and resolve any problems on the existing system(s) supported and is aware of integration points with other systems
* Demonstrates proficiency with one or more technology environments, with the ability to learn and apply new and emerging concepts very quickly.
* Excellent interpersonal, communication, and business partnering skills
* Strategic mindset with strong analytical foundation
* Ability to drive continuous improvement across the team
* Ability to operate in a cross-functional / matrix environment
* High level of personal integrity consistent with Gileads core values
* Ability to analyze complex business problems and evaluate solutions
* Ability to translate complex technical issues into business terms.
* Excellent analytical, problem-solving, and troubleshooting skills
* Good understanding of GxP compliance and 21 CFR Part 11 requirements.
* Experience in general pharmaceutical R&D area business processes covering Safety and Medical Affairs
* Experience working on various Pharmaceutical R&D systems for Safety and Medical Affairs like Argus, Eclipse, Safety Reporting System, IRMS, Veeva Vault (MedDocs/PromoMat), iEnvision, etc.
* Experience working with Computer System Validation in a GxP regulated area
* Experience with Agile, Scrum methodologies and DevOps, Cloud certification is a plus
* Strong Delivery skills, ability to work in a complex environment and an ability to influence cross-functional teams
* Strong communication skills are a must
* Have the ability to support mission-critical business solutions using IT as a tool.
* Experience working with SaaS applications and monitoring service levels and deployment schedules
* Experience managing a large group of consultants for delivery and sustainment and ensuring the quality of deliverables
* Experience managing change control processes as a gatekeeper.
* Bridges gap between business and IT, for small/ simple IT systems and projects
* Experience in Life Sciences is a must.
