DevOps Lead- PDM

Location
Raleigh
Salary
See job description.
Posted
March 06 2021
Ref
R0017719
Position Type
Full Time
Organization Type
Pharma
Job Type
Staff Scientist


DevOps Lead- PDM
United States - North Carolina - Raleigh

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible


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.

Specific Responsibilities and Skills

The R&D / PDM group within IT department is responsible for working with functional business partners and IT in planning, analysis, design, build, deployment, and support of business applications globally. For large, enterprise-wide programs, Solution Delivery personnel work in conjunction with the Capability Managers to successfully deliver against project objectives - typically leading the applications-related technical work streams. R&D / PDM group also works closely with the Program Management Office (PMO) in delivering a Systems Development Lifecycle methodology (SDLC). This provides the mechanism for ensuring consistency and repeatability in how applications are delivered across the enterprise. This role specifically requires a strong management and leadership experience to work with Capability managers/PMO and functional business partners in the design, deployment, and support of business applications supporting the R&D functional domain. DevOps Lead is responsible for managing a cross-functional team for the development, deployment, and operations of new technology platforms and solutions. Collaborates with Capability Manager and Domain Architect in the proposal of new technologies or features to enable business capabilities with agility, velocity, and quality while optimizing costs. Oversees technical design and implementation of solutions, ensures development execution according to plan. Oversees the operational support, including maintenance, production issue resolution, performance measurements against KPIs. Manages the end-to-end development and operations engagement with solution vendors and managed services.

Essential Duties and Job Functions

General responsibilities for this position will include (but are not limited to) the following:
  • Serves as Development lead on initiatives supporting Research and Development Operations functions. This includes leading or contributing to the requirements analysis, use cases, functional and technical design, architecture, implementation and testing following the Gilead methodologies for software development life cycle.
    • Leads feasibility analysis and assessments for new requirements, including understanding implications for the current and future and selection of new systems/applications if required. This includes developing high level proposal with timelines, tasks and resources associated for a project.
    • Act as a subject matter expert on Pharmaceutical Development and Manufacturing (PDM) functional areas namely Manufacturing, Supply chain, PLM, and Quality Systems.
    • Responsible for managing functional PDM IT development resources and accountable for project work estimates. Anticipates change and escalates accordingly.
    • Provides direction, functional guidance, and inputs to technical teams on complex requirements/ development, configuration and implementation efforts, enhancing the expertise of IT colleagues.
    • Communicates broadly and maintains awareness of projects or changes to other systems that may impact enterprise systems to ensure there is no degradation of service.
    • Contributes to proposal of new technology solutions, technical or architectural strategies, or processes to address business or IT needs, taking full consideration of costs and benefits
    • Contributes technical expertise in the architectural design involving integrating multiple technology solutions
    • Leads in RFP process, feasibility analysis, and vendor proposals for new technology solutions
    • Provides resource requirements, level of effort estimates and contributes to solution implementation planning
    • Identifies and considers trade-offs and risk mitigation options
    • Provides technical advice in the design and support of technology solutions
    • Oversees technical design and implementation of solutions according to plan
    • Ensures development and deployment execution align with standards, methodologies and processes
    • Manages issues and risk escalation impacting development and operations
    • Oversees operational support plan development for technology solutions defining KPIs, and monitors the operating efficiency against KPIs.
    • Ensures ongoing support and maintenance, troubleshooting, root cause analysis, and problem resolution of systems and applications in production
    • Defines strategy to maintain a state of compliance and audit readiness of systems and ensure resource availability to implement the strategy
    • Oversees managed services and solution vendor
    • Partner with Training & Change Management lead to support a strategy for consistent and timely communication related to R&D applications and its adoption with its user-base
    • Develops subject matter expertise within junior IT staff in overall PDM solutions (Kinaxis - RapidResponse, Oracle Agile, Appian, Quality Systems (QMS, LMS, Veeva, Maximo), MES, SAP) and its integration with rest of R&D and PDM ecosystem to drive ongoing enhancements, upgrades, and integration effort.
    • Responsible for vendor management and leading external implementation resources partnering with Gilead towards the delivery of PDM projects.
    • Responsible for drafting/reviewing high-level design and functional requirements for enterprise PDM systems.
    • Support Validation/QA teams on ensuring GxP compliance of R&D 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.


Knowledge, Experience and Skills

Must have demonstrated implementation experience of serialization in a Bio-pharmaceutical industry.
  • Laser focused and strong delivery experience managing large, complex projects.
  • Requires deep understanding of drug development and clinical trial business processes and high domain expertise in Clinical Operations and Clinical Data Management.
  • Familiarity with a range of clinical trial information systems such as Kinaxis, Oracle Agile (PLM), Trackwise, Veeva Vault, Compliance wire (UL), Werum MES, IBM Maximo (Asset Management), SAP/Oracle ERP, Orchestrate Production Scheduling, SharePoint, Tableau and Spotfire)
  • Hands-on-experience or strong familiarity needed with cloud computing, preferably aws - Lake Formation/Redshift/Sage Maker, etc.
  • Strong familiarity on Middleware tools such as Dell Boomi, Denodo, APIGEE, SOA, Informatica
  • Strong knowledge on Python, R and visualization tools such as Tableau, Spotfire, PowerBI, is essential
  • Demonstrated ability to deliver large, complex, programs involving system and process reengineering and integration.
  • Proven ability to collaborate with senior functional leaders to set vision, drive innovation and facilitate transformation to meet evolving business needs and priorities.
  • Applies strong analytical and business communication skills.
  • 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 many 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.
  • Experience implementing and managing clinical drug development systems.
  • Good understanding of GxP compliance and 21 CFR Part 11 requirements.


Basic Qualifications
  • Associates Degree and Fourteen Years Experience OR Bachelor's Degree and Twelve Years' Experience OR Masters' Degree and Ten Years' Experience OR PhD and Eight Years' Experience


Preferred Qualifications
  • Excellent at interpersonal skills and relationship development.
  • Strong development and technical experiences in the relevant technology
  • Strong leadership and management skills and be able to make critical decisions
  • Experience with leading globally dispersed technical delivery teams
  • Possess strong leadership skills and be able to make critical decisions.
  • Extensive experience in stakeholder management, dealing with senior management up to the executive level.
  • Extensive knowledge of capabilities and constraints of the technology
  • Expert understanding of all relevant application development processes and methodologies
  • Current with industry technology capabilities and trends, including competing technologies
  • Good understanding of processes and tools associated with the Pharmaceutical industry
  • Expert in implementing standard ITIL processes to support operations for technical solutions
  • Excellent in risk, conflict, and escalation management
  • Strong executive-level verbal and written communications.
  • Specific experience in the Life Sciences/Pharma/Medical Devices/Healthcare industries is preferred

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.


To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---North-Carolina---Raleigh/DevOps-Lead_R0017719-2





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