Jazz Pharmaceuticals

  • Senior Manager Systems Administrator

    Job Post Information* : Posted Date 1 week ago(12/5/2018 9:12 AM)
    ID
    2018-3967
    # of Openings
    1
    Min. Exp. (Yrs)
    8
    Category
    Research & Development
    Advertised Location : Location
    IE-Dublin
    Job Post Information* : External Company Name
    Jazz Pharmaceuticals
    Job Post Information* : External Company URL
    https://www.jazzpharma.com/
    Advertised Location : Address
    Waterloo Exchange
    Advertised Location : Postal Code
    4
  • Overview

    Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.


    Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.


    We are looking for the best and brightest talent to join our team.  If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals. 

    Position Profile

    This position is responsible for managing the R&D business requirements for the Quality Management System (QMS). This role is directly responsible to identify, design, implement, and support design capabilities together with providing key support in relation to the technology solution.  S/He will deliver QMS business analysis, security, data management, computer system validation and end user training to support the R&D Organization.

    Essential Functions

    • Support Global R&D by assuming primary responsibility as System Administrator for the R&D Quality Management System (QMS) including Deviations, CAPAs, Notice of Events, Change Controls, Audits, Document Management,  maintenance of tracking license management and user management, creating user accounts, assigning security profiles, user roles and permission sets.
    • Maintain the validated state of the system, troubleshooting and escalating issues that impact expected performance of system. Work cross-functionally with IT and other stakeholders to maintain the system and resolve technical issues.
    • Work with the platform vendor to resolve issues while ensuring cost management controls.
    • Function as the R&D Quality SME for the management of routine platform upgrades. Assess system upgrades and partner with the Quality Systems team, provide impact assessment to current state and creation of appropriate testing schemes.

    • Continuously monitor the performance of the system to ensure it is “fit for purpose”.
    • Actively manage system performance on daily basis to ensure maximum action time.
    • Support business owners when technical issues arise.
    • Monitor user feedback and execute continuous improvement initiatives.
    • Implement a Change Advisory Board (CAB) system for enhancements and implement a dashboard of operating the implementation
    • Develop and continuously support a “super-User” community within R&D organization
    • Train and educate R&D organization staff on how to properly author and manage Deviations (Investigation, Root Cause Analysis, CAPA, Effectiveness Checks)
    • Model and encourage adherence to the Jazz Values and Mission.

    Required Knowledge, Skills, and Abilities

    • Education with a minimum of 8+ years of pharmaceutical experience
    • Quality System experience is required
    • Proven ability as System Administrator
    • Extensive knowledge of ICH Guidelines, FDA and global Regulatory Standards and associated Guidance/Guidelines
    • Highly resilient and achievement-oriented, with the ability to succeed in an environment that demands fast but well-founded decision-making on a vast number of multidisciplinary issues
    • Exceptional written and verbal communication skills

    Required/Preferred Education and Licenses

    • Bachelor’s Degree in Business or Life sciences is preferred; however extensive practical experience is equally important.
    • Six Sigma or similar certification is preferred but not required

    Description of Physical Demands

    • Occasional mobility within office environment.
    • Routinely sitting for extended periods of time.
    • Constantly operating a computer, printer, telephone and other similar office machinery.

    Description of Work Environment

    • Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
    • Frequent computer use at workstation.
    • May move from one work location to another occasionally.
    • Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.

    Jazz Pharmaceuticals is an Equal Opportunity Employer.

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