For its biopharmaceutical client, located in Lausanne, Kelly Scientific is looking for a
Clinical Quality Specialist
Permanent position - 100%
To ensure that clinical studies sponsored by the client and pharmacovigilance activities related to Investigational Medicinal Products (IMPs) are conducted in compliance with international guidelines (Good Clinical Practices (GCP) and applicable regulations, through the maintenance and constant improvement of adequate quality systems.
Your main responsibilities:
- Act as GCP representative for the Clinical Development department and actively support the development of appropriate clinical development processes, systems and tools to ensure compliance with GCP;
- Follow-up until resolution on all Corrective and Preventive action plans associated with clinical and pharmacovigilance activities resulting from any source (e.g. deviations, audits and inspections, improvement suggestions);
- Tracking and monitoring the Quality Events (Deviations, Change Controls, CAPAs and other events) and communicating to Management the monitoring trends and related improvements in line with the applicable regulations/guidelines.
- Promote the Quality Culture and actively collaborate to the GCP training activities through the company Development organization.
- Perform and coordinate the appropriate training of concerned collaborators involved in GCP activities through the oversight of the company training management system (Ennov Training) and the setting-up/delivery of specific training sessions on clinical quality subjects, new/revised processes, regulations/guidelines, company improvement initiatives, as needed;
- Coordinate the external audits planning of investigational sites and Contract Research Organizations/Vendors and ensure review and follow-up or related CAPAs. Communicate to Management the CAPAs monitoring and related improvements;
- Coordinate the internal audits planning, support the establishment of the CAPAs and ensure regular follow-up of CAPAs with the internal auditees. Communicate to Management the CAPAs monitoring and related improvements;
- In collaboration with concerned functions, coordinate the preparation and assist in hosting external GCP audits of the company (e.g. company's partners) as well as of regulatory inspections of the company, investigational sites, vendors and partners;
- Maintain the Clinical Development Quality Systems and related SOPs in compliance with the laws and regulations governing GCP and the applicable guidelines for the pre-marketing pharmacovigilance (PV) activities.
- University degree;
- 2 to 5 years of experience in managing Clinical Quality Management
- Experience in managing tracking systems such as CAPAs database resulting from GCP audits (CROs, TMF, Investigational Sites and CSR) as well as deviations, changes tracking systems;
- Knowledge of GCP;
- Experience in maintaining quality SOP's;
- Good practical experience in using validated electronic quality systems tools (TrackWise, Veeva, Ennov, etc);
- Knowledge of computerized systems validation;
- Rigor, flexibility, adaptability and organization;
- Pragmatism focused on efficiency and continuous improvement;
- Capacity to think strategically and to keep an overall view while bringing efficiency to daily detailed activities.