Profile Group Published: September 29, 2021
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.
- 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.
- A permanent position in an innovative, dynamic and fast growing company.
- A full time job and permanent contract.
- Located in Liège.