EVERSANA

  • Quality Systems Manager

    Job Locations US-CO-Wheat Ridge
    Job ID
    2019-4504
    # of Openings
    1
    Category
    Compliance Services
  • Overview

    OUR CULTURAL BELIEFS

    Patient Minded I act with the patient’s best interest in mind.

    Client Delight I own every client experience and its impact on results.

    Take Action I am empowered and empower others to act now.

    Grow Talent I own my development and invest in the development of others. 

    Win Together I passionately connect with anyone, anywhere, anytime to achieve results.

    Communication Matters I speak up to create transparent, thoughtful and timely dialogue.

    Own It I hold myself and others accountable for results.

     

    THE POSITION:

    The most important aspect of the Quality Systems Manager position is to be quality system minded with experience in Quality System implementation, project management, workflow management, onboarding/off boarding activities for new QMSS clientele as well as day to day management of Document Control/Training Management Systems and Team.

    Responsibilities

    ESSENTIAL DUTIES AND RESPONSIBILITIES:
    Our employees are tasked with delivering excellent business results through the efforts of their teams.  These results are achieved by:

    • Developing and implementing of quality assurance programs associated with QMSS systems used within EVERSANA and external clients.
    • Client onboarding, system and workflow setup and configuration
    • Training internal/external client users on QMSS systems
    • Facilitating QMSS systems workflow lifecycle management, and system administration
    • Ensuring contractual deliverables are met with each client to its satisfaction
    • Designing, execute, manage software validations for QMSS systems
    • QMSS systems metrics and reporting
    • Responsible for the ongoing review, strategy development, and operational planning to ensure that all QMSS programs meet applicable regulations and standards
    • Ensuring quality processes and good documentation practices are being executed in all aspects of quality systems managed
    • Tracking documents through system workflow processes
    • Interacting with document originators and approvers to ensure document change control loop is completed
    • Releasing documents in the document management system per defined procedures
    • Formatting and uploading documents into QMSS systems for client access
    • Managing reports and metrics regarding documents within the QMSS systems
    • Providing access and support to key customers of the quality management system
    • Interacting with key customers to manage training matrices in order to ensure proper delivery of training
    • All other duties as assigned

    Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

    Qualifications

    EXPECTATIONS OF THE JOB:

    • Incumbents must understand that careful attention to detail and an understanding that accuracy and precision in all aspects of work are necessary to be considered for the position
    • Incumbents must possess excellent customer relation and problem solving skills
    • Individuals must also be flexible and adaptable to rapid change, tight deadlines and time constraints, and rapid shifts in direction and/or priority
    • Travel – No travel required on a normal basis
    • Hours – Monday-Friday from 8am – 5pm to support client contractual obligations. Additional hours are also required, including evenings and weekends, to satisfy urgent / high priority items and internal/client deliverables. Average 40-50 hours/week 

    The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position.

     

    An individual in this position must be able to successfully perform the expectations listed above.

     

    MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:

    The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.

    • College degree is required; management and/or life science emphasis is preferred.
    • Requires a minimum of 2 years in previous quality system environment (document management, training management, CAPA, etc.)
    • Must have a minimum of 2 years of management experience including hiring, managing performance, metric creation/tracking/presenting, individual and team development with both non-exempt and exempt employees
    • Careful attention to detail and an understanding that accuracy and precision in all aspects of work are necessary to be considered
    • Experience with electronic document control and/or training software is required
    • System Administration  and troubleshooting experience required
    • Excellent written and verbal communication skills
    • Timeliness in processing requests for external Clients
    • Ability to manage multiple projects and deliverables in a timely fashion
    • Ability to manage time, set priorities, and execute processes for multiple clients simultaneously
    • Expertise in Microsoft Office suite of applications, particularly Access, Outlook, Word, Excel
    • Ability to execute processes independently
    • Communication proficiency with internal and client teams
    • Superior communication skill with internal and external customer focus
    • Timeliness in achieving deliverables
    • Organizational skills and detail oriented

    PREFERRED QUALIFICATIONS:

    • Previous experience in a regulated pharmaceutical, medical device, or biologics industry is highly preferred
    • 5 years of management experience is preferred. 
    • Previous supervision in the medical device industry is strongly preferred.
    • Previous FDA regulatory and quality systems experience is highly desired

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