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Director, R&D Quality Systems

  • Job type: Permanent
  • Location: California
  • Salary: Competitive
  • Job reference: 5126556
  • Sector: EPM Scientific, Quality
  • Date posted: 23/01/2018
Director, R&D Quality Systems

A growing Pharmaceutical company with a product on market as well as a strong pipeline of candidates in phase 2 and 3 is currently seeking a  Director, R&D Quality Systems! They have received international recognition and are expanding their headcount for 2018. This company is looking for hands-on individuals to contribute to their continued growth and success. 

The Director, R&D Quality Systems will have the following responsibilities:

Reporting to the Head of R&D, the Director, R&D Quality Systems will be responsible for implementing the R&D quality systems. They will come from a strong, hands-on GCP background and also understand GVP and GLP regulations. They will work cross-functionally with other teams such as Quality, Clinical Operations, and Pharmacovigilance. They will be involved with  CAPA and SOP management, GxP Training programs, Deviation Management, internal and external audits, and managing the electronic R&D QMS. 
  • Implement and maintain R&D Quality Systems 
  • CAPA and SOP management
  • Oversee  GxP Training programs
  • Deviation Management
  • Support internal and external audits 

The ideal candidate will have the following skill set:
  • Bachelor’s degree in Life Sciences
  • Minimum of 10+ years industry experience
  • Strong knowledge FDA and other international regulations
  • Excellent communication skills
  • Strong GCP experience + knowledge of GvP and GLP regulations 
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