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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