PRAHS

  • Dir of Quality Assurance 1

    Job Locations - | US-Remote | EU-Remote
    Posted Date 4 days ago(6/14/2018 7:49 AM)
    ID
    2018-47362
  • Overview

    This position assists in ensuring the company promotes a culture that encourages ethical conduct and a commitment to compliance, resulting in a positive image internally and to customers. This is a cross functional role that interacts with all functions of the organization.

    Responsibilities

    • Defines strategic and functional direction, as well as team/ individual goals and expectations to ensure each QA staff member understands her/his responsibility to know and follow all SOPs and corporate policies
    • Ensures QA staff under their direction effectively executes the QA Operating Plan, including the annual audit plan, approved by senior management
    • Ensures all contracted operational and systems audits are planned, schedule, performed and results reported and documented in adherence to protocols, SOPs, regulations, GxP, and expectations for data accuracy and completeness
    • Defines future work methodologies to better meet customer needs
    • Broadly and globally interprets regulations and guidance documents governing GxP and serves as expert and consultant to PRA stadd and client representatives
    • Ensures all new and updated PRA SOPs are reviewed by QA for clarity, internal consistency and compliance with global GxPs
    • Ensures client audits and regulatory inspections of PRA are prepared and hosted to meet the client’s/inspectors’ requirements and minimize disruptions to ongoing operations
    • Actively participates in the reviewing and hiring of new QA staff and ensures new QA employees are trained and qualified to perform their tasks
    • Provides regular status reports on quality observations to Operational Management, as requested
    • Contributes to training for selected PRA functional groups related to Good Clinical Practice, clinical trials regulations, and the role of QA and PRA staff in ensuring compliance with GCP
    • Mentors and develops new QA managers
    • Provides expert quality assurance advice to Project Teams to deal with or avoid potential regulatory agency compliance concerns
    • Provides guidance and oversight in managing and responding to compliance questions and recolves compliance related issues.
    • Participates in and/or leads, as assigned, GxP realted projects initiated by internal stakeholders
    • Effectively plans, implements, and monitors QA funcitons; and ensures optimal utilization of billable auditing staff

    Other responsibilities may include:

    • Oversight of Quality Assurance Tracking System to ensure that reporting, tracking, trending and analysis of non-compliance issues is performed as required
    • Management, trending and analysis of internally and externally reported non-compliance issues
    • Interactions with various PRA functions to determine needs for process improvement, corrective and preventive actions and risk based auditing approach resulting from trending activities

    Qualifications

    • More than 12 years industry experience
    • More than 8 years QA experience
    • More than 8 years managerial experience required
    • Extensive experience with operational and system auditing, compliance, and SOP development required
    • Must have thorough understanding of EU and/or US clinical trials regulations
    • Understanding of all aspects of clinical research, including protocol development, CRF design, clinical trial management (including laboratory methodologies and clinical examinations), data management, statistical analysis, clinical study reports, and regulatory submissions preferred
    • Read, write and speak fluent English; fluent in host country language required
    • An undergraduate degree or its international equivalent from an accredited institution required, science-related preferred
    • Advanced degree preferred
    • Global experience in a CRO Quality Assurance environment preferred





    PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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