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    Director of Quality - New York, United States - GxPeople Global

    GxPeople Global
    GxPeople Global New York, United States

    4 weeks ago

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    Description
    Director of Quality Opportunity in Top Biotechnology Organization


    Summary:


    Are you a seasoned quality leader seeking an exciting opportunity? Join a top-tier Biotechnology leader in New Hampshire as Director of Quality.

    Lead their quality organization at the site for C>, lead and support Audits and Regulatory Inspections at the site, and lead, develop and direct staff in both QA and QC.

    Responsbilities
    Provide strategic leadership and management for the asset Quality organization.
    Ensure teamwork, high morale, and innovation are fundamental components of the team.
    Develop and execute the Quality strategy aligned with the overall plan for the company.
    Implement continuous improvement initiatives to drive Quality programs.
    Develop, implement, and monitor Quality programs, policies, and procedures to ensure compliance with GMP standards.
    Serve as the point person with industry partners regarding product quality matters.
    Oversee all partner and regulatory authority audits and inspections.
    Evaluate and recommend appropriate enhancements to current Quality systems and processes.
    Create active training and development plans for Quality staff.
    Establish and maintain positive working relationships with customers, FDA, and other regulatory authorities.
    Provide solid, well-informed, actionable Quality support to Operations, R&T, and other functions.
    Be a member of the Site Leadership team.


    Requirements:
    Bachelor's Degree in Life Sciences, Engineering, or Quality Management or related discipline.
    10+ years of direct professional experience in GMP manufacturing and Quality Management.
    At least 7 years in senior leadership positions.
    Experience in aseptic processing
    Expert knowledge of GxP, ISO Standards, FDA, and EMA regulatory requirements related to Cell/Gene/Viral therapy products
    Strong knowledge of current industry trends and technologies.
    Working knowledge of aseptic practices, clean room design/operations, and auditing techniques.
    Excellent organizational and computer software skills.


    This role is only available for US Citizens or green card holders
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