IT Delivery Lead R&D - Raleigh, United States - Gilead Sciences

Description

**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.