Jazz Pharmaceuticals

  • Manager, Audits & Inspections

    Job Locations US-CA-Remote Office Non Sales
    Posted Date 7 days ago(7 days ago)
    Job ID
    2018-3466
    # of Openings
    1
    Category
    Research & Development
  • 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 will lead and participate in various types of GCP/GLP compliance audits for Jazz Pharmaceuticals’ development programs including but not limited to, clinical investigator sites, service providers, and internal systems and processes globally. In addition, this position is responsible for supporting regulatory agency inspections.  

    Essential Job Functions:

    • Conduct/support  GCP/GLP compliance audits of clinical investigator sites, service providers and internal system/process audits in accordance with the annual audit plan to determine compliance status and identify compliance risks
    • Prepare audit reports and communicate audit findings to audit stakeholders as well as R&D Quality Management ensuring understanding of observations 
    • Collaborate with clinical compliance leads to identify audit needs and follow up post-audit activities to ensure appropriate implementation of CAPA, and monitoring successful completion of action items
    • Assist in managing and training external auditors ensuring compliance with Jazz Pharmaceuticals auditing standards and procedures
    • Provide pertinent data to support quality and compliance metrics and trending
    • Assist in the planning of clinical quality audit programs
    • Develop and maintain study specific audit plans (SSAPs)
    • Participate in strategic planning of organizational activities, as required.
    • Support inspection management lead to maintain Jazz R&D inspection readiness at times 
    • Participate in regulatory agency inspection activities pertinent to R&D
    • Domestic and international travel is required

    Qualifications

    • Minimum 5 years pharmaceutical or biotechnology industry experience in performing audits and participating in regulatory inspections
    • GCP audit experience is required, GVP and GLP experience is valuable but not required
    • Knowledge/understanding of the perspectives of regulatory agencies

    Education

    • 4-year degree OR 10+ years’ industry experience plus applicable industry certifications
    • Industry certification in Regulatory Affairs and / or Quality Assurance is preferred but not required

    Competencies

    • Ability to manage multiple priorities simultaneously and work efficiently in a fast paced culture
    • Strong and clear understanding of Good Clinical Practices (GCP)
    • Strong knowledge of applicable global regulatory requirements
    • Must be disciplined, detail orientated and excel in personal time management
    • Collaborate and ability to interact all levels of the organization
    • This position requires highly diplomatic and tactful with critical reasoning skills
    • Strong problem solving and analytical skills
    • Excellent written and verbal communications skills
    • Ability to work independently while also supporting/working in teams collaboratively

    Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

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