Senior Clinical Quality Manager - Switzerland
Want to know company name or location? Company managed [?]
- Our company is a Swiss-based biopharmaceutical group of five companies active in drug development, GMP manufacturing of proprietary drugs, diagnostics, and investment management.
- Our company evaluates and in-licenses promising drug candidates for development.
- Towards the end of the development process, the products are licensed out to pharmaceutical companies for worldwide marketing and sales.
- 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.
- 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.