• Senior Director Global Quality

    Job Locations US-MA-Lexington
    Job ID
  • Overview

    Title: Sr Director Global Quality

    Job Overview:

    The head of Quality is responsible for oversight of the Quality Assurance and Validation departments. This role works closely with manufacturing leadership teams to develop and execute the corporate goals and objectives for the company. The candidate who fills this role is responsible for oversight of the global quality systems and ensuring GMP compliance with global regulatory bodies.


    Job Responsibilities:

    • Develop, implement, manage, audit and maintain GXP quality systems to support commercial and development activities
    • Coordinate and perform all vendor qualification and compliance audits
    • Perform lot release activities, including lot file compliance review
    • Provide oversight for Quality Control activities performed by contract testing laboratories and contract manufacturing companies
    • Develop, manage and maintain a GXP compliant document control system
    • Oversee investigations of all non-conformances (deviations, OOS)
    • Ensure that cGMP requirements and quality standards are recognized, understood and maintained across the Company
    • Ensure in-process and finished products and processes conform to in-house policies and procedures as well as other applicable regulations and guidelines
    • Budgetary and managerial responsibility for Quality Assurance and Quality Control
    • Work across all disciplines (e.g. manufacturing, clinical, R&D, etc.) to ensure that the Company maintains a state of readiness for inspection by regulatory agencies
    • Keep abreast of changes to quality regulations and guidelines, advising the management team of any business implications of these changes
    • Lead quality efforts in corporate development of analytical methods
    • Provide quality guidance to product development projects and programs
    • This individual is the key point person for quality issues escalated from within the function or outside the function


    Job Qualifications:

    • B.S. or B.A. degree (preferably in Life Science) and fifteen years relevant experience in the pharmaceutical or biopharmaceutical industry Quality professional with 10+ years of hands-on experience with increasing responsibility in a QA function
    • Significant experience in either clinical and commercial products, global experience required
    • Hands on experience implementing quality systems in a GXP environment, and direct experience with FDA and other health authority inspections
    • Extensive knowledge of US GXP compliance regulations and industry practices, as well as EU GMP requirements
    • Exceptional leadership and management skills


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