Executive Director Of GCP

San Diego  ‐ Onsite
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Keywords

Description

This company is currently well on its way to going commercial in the US by 2014. They already have drugs, with proven success, on the market in both the EU and Canada. The VP of Quality Assurance has expressed to me how they need an experienced Clinical QA Professional to come in and ease this transition into commercialization. With this great responsibility comes great potential because the company is ready to take off under the watchful eyes of a proven leader.

  • Minimum of 10+ years' experience in the pharmaceutical/biotechnology industry
  • Minimum of 7+ years' auditing in one of the following areas: GCP, GLP, GPvP
  • Expert knowledge of technical concepts required for all aspects of GCP Auditing, to include all types of GCP audits; e.g., Study Sites, Vendors, essential study documentation
  • Solid understanding of domestic and international pharmaceutical/Biotechnology auditing standards
  • Extensive experience supporting regulatory authority inspections of clinical research activities
  • Hands-on experience managing quality and compliance projects and programs
  • Proven ability in driving quality process improvement initiatives.
  • Extensive leadership experience and mentoring skills Thorough knowledge and application of international requirements of Good Clinical Practice (GCP) and ICH Guidelines
  • Strong global knowledge and understanding of regulations applicable to the conduct of clinical trials
  • Strong working knowledge of clinical development and operations
  • Strong communicator with strong verbal, written communication and presentation skills


To find out more about Real please visit www.realstaffing.com
Start date
11/2013
From
Real Staffing
Published at
27.11.2013
Project ID:
632990
Contract type
Permanent
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