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    Director, Quality Management Systems - Cambridge, United States - Apex Systems

    Apex Systems background
    Full time
    Description

    Job#:

    Job Description:

    Director, Quality Management Systems
    Location: Boston,MA(Hybrid / Onsite)
    Therapeutic Area: Small molecule Pharma
    Job Overview: The role requires leading the development, design, and maintenance of the Quality Management System to ensure efficiency, effectiveness, and compliance with quality regulations and standards, reporting to the Head of Quality Assurance.
    Primary Job Responsibilities:
  • Ensure compliance with cGXP regulations by evaluating and advancing quality standards
  • Oversee the design, development, and maintenance of Global GxP e-Quality Systems aligned with business processes
  • Manage the corporate cGxP training program and collaborate with department heads to develop training curriculums for GxP personnel
  • Primary Job Requirements:
  • Bachelors Degree in Life Sciences or a related field
  • A minimum of 10-12 years of increasing responsibility in cGMP/Quality Management Systems
  • Experience with Veeva Quality Vault eDMS/eQMS and Compliance Wire eLMS
  • Candidates must have prior experience in FDA regulated environments and familiarity with Health Authority regulations and guidance


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