Director of Quality and Compliance - Miami - Green Life Science

    Green Life Science
    Green Life Science Miami

    2 days ago

    Description

    Director of Quality Assurance & Compliance (Clinical Research)


    We are seeking a seasoned quality professional to lead and advance clinical research quality initiatives within a high-performing multi-site research environment.

    Key Responsibilities:

    • Provide strategic and operational leadership for quality assurance and compliance across clinical research sites.
    • Ensure day-to-day trial operations adhere to regulatory requirements, industry standards, study protocols, and internal procedures.
    • Lead and coordinate internal, external, and regulatory audits, maintaining inspection readiness and managing follow-up actions.
    • Oversee corrective and preventive action (CAPA) management, quality events, document control, training compliance, and electronic quality systems.
    • Collaborate with site leadership, investigators, and operations teams to maintain consistent quality and compliance across studies.
    • Mentor and manage QA/QC staff, fostering a proactive and inspection-ready quality culture.
    • Support organization-wide quality initiatives, including cross-site audits and continuous improvement efforts.
    • Act as a primary quality liaison in interactions with clients, sponsors, and stakeholders, ensuring clear communication and alignment.

    Qualifications:

    • Extensive experience in clinical research quality within multi-site or networked research organizations.
    • Strong knowledge of FDA regulations, ICH/GCP guidelines, and clinical trial operations.
    • Demonstrated leadership experience in audit management, inspections, and CAPA oversight.

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