Gilead Sciences
Published
September 27, 2021
Location
309 Velocity Drive, Foster City, California
Job Type

Description

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to pursuing scientific invention to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

You will be part of a team that is helping millions of people live healthier, more fulfilling lives. We are a close community where every individual matters and everyone has a chance to enhance their skills through ongoing development. Inclusion is one of our core values, which means we are creating and fostering a work environment where our differences are valued, and everyone feels respected and empowered to bring their authentic selves to work. By joining Gilead, you will further our mission to discover, develop and deliver innovative therapeutics for people with life-threatening diseases.

The Gilead Business Services center in Raleigh’s Research Triangle region will be home to some of the company’s critical shared service teams in North America, including Information Technology, Global Financial Solutions, HR Operations and Procurement Services Desk. These functions provide the necessary support to ensure Gilead’s business runs effectively and efficiently. The center will also be a catalyst for standardization of processes, digital transformation and technology optimization. Please check out more at https://nccareers.gilead.com/

Job Description
The R&D / PDM group within IT department is responsible for working with functional business partners in the design, build, deployment, and support of business applications globally. For large, enterprise-wide programs, Technology personnel work in conjunction with the DevOps Lead and Capability manager against project objectives and have measured outcomes- typically leading the applications-related technical workstreams. R&D / PDM group also works closely with other cross-functional groups within IT namely Security, Worldwide Infrastructure Operations, and Enterprise Platform teams in the delivery of these capabilities leveraging Systems Life cycle (SLC) methodologies. This provides the mechanism for ensuring consistency and repeatability in how applications are delivered across the enterprise. This role specifically requires strong management and leadership experience to work with capability managers and functional business partners in the design, deployment, and support of business applications supporting the Medical Affairs and Regulatory space within the Development Organization. The Technology Lead, a primarily delivery-focused role, is responsible for the technical integrity of delivering application projects while providing technical guidance to business customers and IT project team members. This role has day-to-day lead accountability and leads the project delivery and Operations from a technical solution perspective supporting Regulatory functional areas and works with IT DevOps Lead, Domain Architecture, PMO/other cross-functional groups within IT to perform evaluations and feasibility reviews of business need and/or technology solutions.

Essential Duties and Job Functions
General responsibilities for this position will include (but are not limited to) the following:

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 Implementation Vendor to ensure the effective execution of the projects and services, holding them accountable to project scope, SLAs and KPIs.

Partner with the capability manager to capture, analyze and document functional requirements Specifications

Translate business requirement to functional requirements and communicate them to technical teams

Create/update and review system related documents including validation deliverables

Work as the primary technical and delivery lead with Medical Affairs and Regulatory systems (IRMS, Salesforce, EPRF, LCT, RDMS, SPS)

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 with R&D systems namely Medical Affairs, PV and Regulatory area.

Provide Support for technical implementation activities during functional requirements and design, cost and timeline estimation, and assist in the management and communication to Gilead’s stakeholders.

Participates in business customer idea elaboration and technical problem-solving with potential technical options including proposals, front-end studies, development plans, and presentations, as directed in a consulting role

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

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

Defines technical strategies by performing evaluations, proof of concepts and assessments on the various technical aspects of the proposed project solution

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 technical escalation and resolution during the project lifecycle as it relates to technical decisions

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

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

Communicates proactively with the Project Manager and project team regarding project status

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

Ensures formal technical and technical performance reviews are conducted and provides feedback and suggestions

Ensures that training design documentation and delivery from a technical perspective are in place

Participates in the creation of Request for Proposals (RFP) from a technical perspective.

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

Provides technical consulting and mentorship to coach, train and guide new or junior IT staff, such as to suggest training course options

Serves as an advocate and endorses and enforces technological best practices in collaboration with solution architects

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

Develops, documents and shares technical delivery best practices.

Keeps abreast of industry trends and advancements in relevant technology

Consultative role on technical support areas, working closely with the System Manager

Partner with capability manager, global capability leads and portfolio managers to create the business case and Deliver the Projects to support Business strategy.

Partner with Implementation Vendor to ensure the effective execution of the projects and services, holding them accountable to project scope, SLAs and KPIs.

Partner with the capability manager to capture, analyze and document functional requirements Specifications

Translate business requirement to functional requirements and communicate them to technical teams

Create/update and review system related documents including validation deliverables

Provide Support for technical implementation activities during functional requirements and design, cost and timeline estimation, and assist in the management and communication to Gilead’s stakeholders.

Responsible for vendor management and leading external implementation resources partnering with Gilead towards the delivery of serialization and/or other commercial manufacturing projects.

Responsible for drafting/reviewing high-level design and functional requirements for enterprise serialization systems and integration to packaging execution systems

Support Validation/QA teams on ensuring GxP compliance of serialization and other commercial manufacturing systems with the corporate standard for IT change management and IT SOPs following 21 CFR Part 11 and Annex 11 requirements.

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 Gilead’s 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

Advises clients/business analysts on discrete technology-related business problems, leveraging appropriate IT colleagues and/or vendors as appropriate. Formulates options including assessing their relative merits and risks, and works with clients/business analysts to determine the best solution.

Supervise a team of technical professionals, with full responsibility for performance management.

Acts as a technology mentor to team members.

Basic Qualifications:
High School Degree and Twelve Year's Experience OR Associates Degree and Ten Years Experience OR Bachelor's Degree and Eight Years’ Experience OR Masters' Degree and Six Years’ Experience

Preferred Qualifications:
Must have demonstrated implementation experience of Medical Affairs, PV and Regulatory systems in a Bio-pharmaceutical industry.

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 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.

Good understanding of GxP compliance and 21 CFR Part 11 requirements.

Experience in general pharmaceutical R&D area business processes

Experience working on various Pharmaceutical R&D systems like IRMS, Salesforce, Oracle Siebel, Veeva Vault, OpenText Documentum, Generis CARA, Lorenz docuBridge, Argus, etc.

Experience working with Computer System Validation in a GxP regulated area

Professional written, verbal, & interpersonal skills

Ability to multi-task effectively & work independently

Strong Delivery skills, ability to work in a complex environment and an ability to influence cross-functional teams

Strong communication skills are a must

Experience in GxP applications (and Good Documentation Practices).

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

Track record working in a fast-paced, highly iterative environment

Strong Listener: Be able to patiently listen to understand the business needs

Communication – Should be able to communicate with business stakeholders and be able to communicate complex solutions and value in business terms. Verbal communication skills are critical and the ability to adapt and learn to changing business environment and domains is a must

Experience in Life Sciences is a must

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