Clinical Quality Officer

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