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Senior Clinical Quality Manager - Switzerland  

Company managed [?] Still accepting applications

Posted on : 11 April 2017

Project Description

Description:
  • 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.


 
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. 
 


Your profile 
  • 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.
 


Offer:   
  • 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.