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Vice President, Quality

Chicago, IL 60632

Posted: 06/27/2024 Employment Type: Direct Hire Job Category: Quality Job Number: 3730

Job Description

Our client is developing first-in-class therapies designed to reprogram the immune system to achieve antigen-specific tolerance for immune-mediated disease. They are seeking a Quality Leader to grow the capability of the quality assurance and quality control functions for the business. This is a highly visible role, reporting directly to the Chief Operating Officer.

Responsibilities include:
  • Design and implement a quality management system (QMS) that addresses Phase 3 readiness
  • Oversee all QA and QC activities throughout the product lifecycle, from early clinical to clinical phase
  • Conduct internal audits and oversee external audits from clients, regulatory agencies, and partners
  • Recruit and develop a high-performing team of quality professionals

Requirements:
  • Bachelor's degree in a science discipline
  • Minimum of 15 years of experience in Quality Assurance, inclusive of senior leadership roles and experience in Quality Control
  • Quality Assurance experience must span across a broad range of functions, covering Quality systems, third parties, pre-clinical, GMP manufacturing and Phase 3 Clinical.  Experience in commercial phase preferred.
  • Recent exposure to large molecule therapies
  • Ideal candidate will have experience across both large established and small companies
  • Strong leadership and communication skills
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