Clinical Quality Officer

    Profile Group Published: September 29, 2021
    Location
    Liège, Belgium
    Job Type

    Description

    Function

    The Clinical Quality Officer will be a part of a quality supportive team that fosters constructive collaboration in support of our clinical development programs.

    • He/She will support and work with our clinical study management team and teammates across R&D Quality.
    • Serves as Clinical Compliance/Qualitty Lead for assigned clinical trial programs.
    • Handles multiple projects and ensure overall and timely completion of tasks.
    • Develops audit plan for assigned projects and manages audit plan execution.
    • Manages and/or leads GCP routine and complex audits including but not limited to investigator sites, internal processes, and vendors.
    • Works closely with clinical study management teams to provide expert clinical compliance/quality information, manage identified issues, and support continuous improvement.
    • Advises core teams independently for routine compliance/quality inquiries.
    • Assists in readiness preparation, and/or directly support regulatory agency inspection.
    • Assists in coordination of response to any findings.
    • Supports deviation identification, reporting, and CAPA development.
    • Ensures that the monitoring of studies is correctly carried out and supports this activity.
    • Participates in risk management activities.
    • Participates in intra/inter-departmental teams that support operations (e.g. evaluation of a new regulation).
    • Evaluates, writes and/or reviews operating procedures (e.g. SOPs), and performs other activities in support of an integrated cross-functional quality management system (QMS).
    • Generates and provides metrics, status and trend reports and other information, as required by management.
    • Maintains an up to date and in-depth knowledge of appropriate national and international GCP legislation and guidelines; and the impact to assigned business area processes and procedures.
    • Fosters a commitment to quality in individuals and a culture of quality within the organization.

    Profile

    • Master in science with 5+ years of relevant experience.
    • Minimum 3 years in Good Clinical Practice (GCP) required, with international audit and compliance experience.
    • Recognized as an expert resource on a range of clinical compliance topics.
    • Experience supporting regulatory authority inspections.
    • Participation in process improvement initiatives.
    • Strong verbal and written communication skills and interpersonal skills and facilitation skills.
    • Proficient in Microsoft Office suite.
    • Excellent organization skills and project management, able to manage multiple projects.
    • Able to work equally well as part of a team or independently.
    • Fluent in English.
    • Experience in other GxP area is an asset.
    • Experience in Medical Device field is an asset.
    • Proactive and willing to work in a start-up environment.

    We Offer

    • A permanent position in an innovative, dynamic and fast growing company.
    • A full time job and permanent contract.
    • Located in Liège.

    APPLY HERE

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