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Director, GCP QA

  • Job type: Permanent
  • Location: South San Francisco
  • Salary: $180000 - $235000 per annum
  • Job reference: MERZ11012017
  • Sector: Quality Assurance, EPM Scientific, Quality
  • Date posted: 01/11/2017
  • Multi-Million Biopharmaceutical Company
  • South San Francisco, CA
  • $180,000 – $235,000+ Bonus + Benefits + Excellent Career Growth
A growing pharmaceutical company is looking to hire a DIRECTOR, GCP QUALITY ASSURANCE to join the team! This company is one of the leaders committed to developing, discovering and commercializing novel therapeutics in order to address blood-based disorders. This pharmaceutical company is family oriented, has a great work-life culture, and has been expanding in size! They offer a competitive base salary, bonus, benefits, and professional career growth!

The DIRECTOR, GCP QUALITY ASSURANCE will be the leader to the implementation and design of risk-based GCP audit programs and compliance oversight. This individual is going to be responsible for the control, coordination, planning and continuous success and improvement of systems and processes to ensure the quality of the clinical studies conducted by the company. The DIRECTOR, GCP QA will be responsible for supporting the external and internal auditing activities and plans, the implementation and development of GCP related quality systems, and training for the staff.  

This is a new role and will be tailored around their ideal candidate!

The Director, GCP QA will perform the following responsibilities:
  • Conduct GCP audits of Clinical Laboratories, Clinical Research Organizations, Clinical Investigator sites, Phase I Units, and internal operations
  • Provide education and training internally in global GCP standards
  • Assist with the development of Clinical controlled documents such as forms and SOPs
  • Lead Clinical QA audit activities
The Director, GCP QA will have the minimum requirements:
  • Past experience working within a Quality environment in relation to GCP (10+ Years)
  • Strong communication, organizational and leadership skills
  • Must be team oriented
  • Willing to roll up their sleeves and do the work!
  • Looking for career growth
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