Quality Assurance Manager

Boston, MA

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Our client is seeking a Contract Quality Assurance Manager near Boston, MA!

Our client is an integrated global leader in pharmaceutical synthesis & specialty ingredients, delivering outstanding performance, unrivaled market responsiveness, and tailored-made solutions to its customers. The company offers their customers custom-development small-molecule active pharmaceutical ingredients as well as in vitro diagnostic services. They are a mid-sized company that is experiencing growth, offering potential for upward-mobility in the future.

Specific Responsibilities:

  • Proactively perform Quality Assurance functions in full compliance with current Good Manufacturing Practices (cGMP)
  • Manage team of Quality Assurance Specialists for daily planning, maintenance, and operation of the company’s quality systems, including but not limited to:
    • Batch Record Review & Release
    • Quality Investigations (including Deviation Control), material control, and change controls
    • Corrective Action / Preventative Action (including effectiveness) and customer complaints.
  • Manage team of Document Specialists operating the site’s document control system, including:
    • Documentation review/approval and document change control
    • Record Retention of Quality Records (Archival and retrieval)
    • Contribute to the Supplier Qualification program, including documentation, correspondence and external auditing required for vendor approval and ongoing compliance.
    • Contribute to the internal audit program to ensure continued compliance to the Quality Program and cGMP
    • Maintain system for monitoring of Quality Metrics for reporting (Local Management and Corporate)
  • Contribute and provide oversight to Management Quality Review (QMR) Program


  • Bachelor’s degree in a related field of science, or equivalent formal training and experience
  • 10+ years working in a Quality Manager role under cGMP
  • Thorough knowledge of GMP principles, specifically 21 CFR 211 and ICH Q7
  • Experience with electronic Quality Management Systems
  • Understanding of EMA Quality standards and principles (preferred)