QA Director

This position is with a privately held pharmaceutical company, specializing in semi-solid and liquid products.  The QA Director will manage and build a group responsible for the QA functions supporting both R&D and manufacturing.  Responsibilities will include, but are not limited to, the following:

 
ensure contract organizations are assessed for GxP compliance
maintain and develop internal audit programs to support regulatory compliance and also audit internal / external producers of clinical trial supplies
release R&D products to meet both company and regulatory requirements
ensure approved API and API Intermediate supplier system
ensure a system operates to manage change control, OOS?s, and deviations
host FDA inspections

 

Qualified candidates will have an advanced in Chemistry or related discipline, as well as at least 10+ years of experience within the pharmaceutical industry.  At least 5 years of QA management experience is also required.  Experience must include QA and auditing experience in a GMP environment and must be familiar with GLP.  In addition to this QA experience, qualified candidates will also have served in a technical position within R&D.  Must have a good understanding of FDA and other regulations.