Quality Assurance Manager


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


  • Prior Quality Managerial experience in a fast-faced regulated environment
  • Experience in API Manufacturing and/or a chemical manufacturing environment
  • Experience as an administrator of electronic quality management systems
  • Regulatory Compliance experience


  • Excellent writing and communication skills
  • Proficient with Microsoft Office software; experience building and using databases (e.g. Microsoft Access);
  • Self-motivated and able to work independently when necessary, set goals, organize and follow project plans due meet pre-determined deadlines
  • Thorough, detail oriented and willing to follow through on all aspects of a task required for successful completion
  • Ability to thrive in a very fast-paced API contract manufacturing environment


  • Proactively perform Quality Assurance functions in full compliance with current Good Manufacturing Practices (cGMP)
  • Demonstrated working knowledge of 21 CFR 211 and ICH Q7. Understanding of EMA Quality standards and principles preferred
  • 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 & Batch Release
    • Quality Investigations (including Deviation Control)
    • Material control
    • Training (including job-skills and effectiveness)
    • Change control
    • Corrective Action / Preventative Action (including effectiveness)
    • Customer Complaints
  • Manage team of Document Specialists operating the site’s document control system, including:
    • Documentation review and approval
    • 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