Director of Quality Assurance

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Location
Boston, MA
Salary
$170,000 - $195,000
Job Type
Direct Hire
Degree
Bachelor of Science, Master of Science, Doctor of Philosophy
Date
May 22, 2017
Job ID
2477995
Director of Quality Assurance

My client is focused on cell therapy products, and they actively seek a QA Director.  The ideal candidate will take on the following tasks:
  • Establish, develop and manage the quality management system for the firm.
  • Build the quality department infrastructure to assure compliance to company, industry standards and the applicable regulatory requirements.
  • Interface with external personnel (vendors, partners and regulatory bodies) and internal personnel (management and staff) to drive Quality Assurance tasks and milestones.
  • Handle audit planning (including supplier audits), conduct, findings, responses, and corrective and preventative actions. 
  • Perform and direct quality system internal audit activities and drive improvements within the local quality system.
  • Design and implement a phase-appropriate quality management system for a firm with both internal and outsourced manufacturing.
  • Support quality management sub-systems to achieve compliance and consistency in management reviews, CAPA, design, design change, document control, process control, complaints, training, etc.
  • Oversee Document Control and Employee Training programs.
  • Assimilate relevant technical, regulatory, and compliance information to formulate suitable strategies and tactics to satisfactorily resolve complex problems.
The ideal candidate will possess the following qualities:
  • BS Degree and 10+ years of quality experience in biotech or pharma
  • ASQ or RAPS certification is a plus.
  • Working knowledge of compliance best practices for cell-based products and understanding of compliance nuances related to combination products.
  • Experience dealing directly with FDA and notified bodies and knowledge of appropriate FDA, ISO, and global regulations regarding quality systems is a plus.