Compliance Team, Inc.

  • IT Project Manager

    Job Locations US-MO-St. Louis
    Posted Date 2 weeks ago(2 weeks ago)
    ID
    2018-1238
    # of Openings
    1
    Category
    Management
  • Overview

    Compliance Team, Inc. is a leading provider of technical consulting services to our clients in the pharmaceutical, biotechnology, and medical device industries in the areas of commissioning, qualification, validation and regulatory compliance.  We are proud of our talented professionals and the major contributions they make to our clients’ successes on mission critical projects. 

     

     

    Become part of our team. We have exciting opportunities for Information Technology Project Managers.  We seek top-notch professionals with project management experience to provide implementations for IT critical systems in the bio-tech, pharmaceutical and/or medical device industry. 

     

    Responsibilities

    There are two roles associated with this posting:

    Role 1:  Business Systems PM

    • Drive assigned projects with high energy and tenacity – often pulling SMEs and stakeholders along.
    • Developing project documentation, communications and stakeholder plan development and execution
    • Providing project and deliverable status updates, financial analysis, risk and issue tracking, analysis and problem resolution; perform project manager responsibilities as assigned during all project phases (initiation, planning, execution, control and close)
    • Directly interface with business users and stakeholders to gather business and functional requirements for systems and solutions to be implemented
    • Connect people to work and track diligently – with extensive communication and follow-up across project SMEs and stakeholders.
    • Ability to interact and facilitate meetings with Pfizer BT core solution teams, vendors and other 3rd party stakeholders throughout the duration of projects
    • Execute SDLC documentation for computer system implementation projects including developing user and functional requirements; technical and functional business process flows, use case, test case and test script documents; perform functionality, usability and testing during required project phases
    • Diligently and with cadence of purpose – provide routine updates (Weekly reports, meeting minutes, monthly project quad status). Consistently update Smartsheet master project and capacity plans to PMO.
    • Manage multiple tasks across multiple owners while constantly updating management and stakeholders weekly.
    • Escalate Issues quickly to appropriate business system owner or Site Lead.

    Role 2: Virus Patching Project

    • Perform project management responsibilities during all assigned project phases (Initiation, Planning, Execution, Control, and Close).
    • Implement several security/business-critical computer systems and patch infrastructure, automation, and manufacturing systems.
    • Co-ordinate between the site and global corporate operations in a matrixed organization.
    • Faciltate meetings between core solution teams, vendors and 3rd-party stakeholders.
    • Develop project documentation to perform business analyst work, such as change management.
    • Run the multi-disciplinary project single-handedly (no direct reports)
    • Perform Software upgrates
    • Perform security patching
    • Manage Communications
    • VMware infrastructure migrations
    • Interface with Validation Team
    • Interface with business user teams
    • Interface with Manufacturing, Laboratories and all other teams

    Escalate issues quickly to appropriate business system owner or BT Site Lead

    Qualifications

    • Proficient in English
    • Bachelor degree in Computer Science, Information Technology or related field
    • 5 – 7 years of computerized system experience, preferably in an FDA-regulated environment.
    • Strong experience with WBS/Project task elucidation and interative refinement of scope, tasks, and estimations
    • Previous project management experience, with certifications in SDLC or other IT project management methodologies:  Agile development a plus.
    • Familiarity with Good Manufacturing Pratices, Computer System Validation regulations, 21 CFR Part 11, and Good Documentation Practices. (e.g. writing validation documents such as Validation Master Plans, Validation Protocols, SOPs, Verification Plans, Test Scripts and Part 11 assessments)
    • Knowledge of FDA regulations and pharmaceutical and or medical device GMP's
    • Excellent self-management, time management, and problem-solving skills, with ability to multi-task/multi-project.
    • Ability to function in multidisciplinary teams, possessing excellent documentation, presentation, training, and computer skills.

     

     

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