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    Senior Director Clinical Quality Assurance - San Francisco, United States - Meet

    Meet
    Meet San Francisco, United States

    Found in: Appcast US C2 - 1 week ago

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    Description

    We are partnering with an innovative biotech in the treatment of liver and cardio-metabolic diseases. They are looking to add a leader to their Quality Assurance team in one of their phase III trials.

    Responsibilities:

    • Establish and maintain the GCP QA programs, policies, and procedures and ensure cGCP compliance of clinical trials.
    • Act as the primary business partner with internal organizations including Clinical Operations and Clinical Development.
    • Act as the primary contact for vendors, contract facilities and contract service providers related to quality aspects of clinical trials.
    • Oversee and manage the auditing and qualification process for clinical trial vendors, suppliers and contract organizations and facilities.
    • Ensure compliance with applicable health authority regulations and guidelines for document management, TMF, and software used in GCP processes.
    • Responsible for writing and maintaining GCP SOPs and providing associated training.
    • Accountable for the QA review of clinical trial documentation and documents submitted to regulatory agencies.

    Qualifications:

    • Bachelor's degree in a scientific discipline (e.g., biology, chemistry, pharmacy).
    • 12 years of relevant biotechnology experience including 3+ years in an applicable Sr. Quality leadership role.
    • 8 years GCP Quality Assurance experience.
    • Experience in developing and maintaining QA systems.
    • Experience working with CROs
    • Knowledge and understanding of drug development process, global regulations, and interfacing related to GXP, and GCP authorities.
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