Founded in 2012, EyeD Pharma is a pharmaceutical company dedicated to the development of innovative drug products in ophthalmology. EyeD Pharma is developing innovative products based on a new delivery pathway of well-known drugs with the aim of improving quality of life of patients in various ocular pathologies.
In 2019, UniD Manufacturing was born, which brings together production activities. In parallel with its R&D and industrialization activities, EyeD Pharma started in 2017 a commercial activity of medical devices (equipment and consumables) for eye surgery.
EyeD Pharma and UniD Manufacturing lay the foundation stone of their future headquarters. This collaborative environment will allow a positive synergy between R&D activities, production, logistics and administration. Our technological platform will be in the Science Park of Liège and will be up and running from 2022.
To support its development, EyeD Pharma is hiring a Clinical Quality and Compliance Specialist
The Clinical Quality and Compliance Specialist 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 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 exécution;
- Manages and/or leads GCP routine and complex audits including but not limited to investigator sites, internal processes, and vendors;
- Trains and manages contracts auditors;
- Works closely with clinical study management teams to provide expert clinical compliance information, manage identified issues, and support continuous improvement;
- Advises core teams independently for routine compliance 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 8+ years of relevant experience
- Minimum 5 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
EyeD Pharma offer
- A permanent position in an innovative and dynamic and fast growing company
- Full time
Please send your CV and cover letter in English to : email@example.com