Debiopharm Group™ is a Swiss-headquartered global biopharmaceutical group including five companies active in the life science areas of drug development, GMP manufacturing of proprietary drugs, diagnostic tools and investment management. Debiopharm International SA is focused on the development of prescription drugs that target unmet medical needs. The company in-licenses and develops promising drug candidates. The products are commercialized by pharmaceutical out-licensing partners to give access to the largest number of patients worldwide.
For our Quality Management & Documentation Department, we are looking for a
Senior Clinical Quality Manager
Your main responsibilities
- Ensure the maintenance of a clinical quality system in compliance with the laws and regulations governing the conduct of clinical trials (GCP) and pre- and post-marketing pharmacovigilance (PV) activities;
- Manage in collaboration with the SOP Coordinator DPI procedures related to Good Clinical Practices (GCP) and Good PV Practices (GVP);
- Collaborate with concerned functions in the development of appropriate processes, systems and tools to ensure GCP and PV inspection readiness;
- Perform external audits (Investigative sites, CRO's, Licensees, vendors);
- Perform on a regular basis internal system audits of clinical trials-related as well as pre- and post-marketing pharmacovigilance activities;
- Follow-up until resolution on all Corrective and Preventive action plans associated with clinical and pharmacovigilance activities;
- Ensure the training of collaborators involved in GxP activities through the administration of the corporate training management system and by specific training sessions.
- University degree (for instance Master's degree or Ph.D. in a biomedical subject, nursing degree, etc.);
- 10 years of experience in Quality Management including involvement in managing clinical/pharmacovigilance compliance audits & inspections;
- Excellent knowledge of GCP as well as PV processes;
- Experience in setting and updating clinical quality SOP's;
- Experience in the mechanism of multiple vendors oversight;
- Excellent team-working and interpersonal skills, with the flexibility to actively contribute within multidisciplinary and multicultural teams;
- Team player, used to influence through a matrix organization;
- Capacity to think strategically and to keep an overall view while bringing efficiency to daily detailed activities;
- Perfect command of both French and English;
- Knowledge of computerized Systems Validation is an asset.
Debiopharm can offer you
- An international and highly dynamic environment.
- The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry.
- The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.
If you fit this profile please send your application using this form.
For more information : www.debiopharm.com