Senior Director of Quality Assurance GCP - San Jose - BioPhase

    BioPhase
    BioPhase San Jose

    1 day ago

    Description

    Senior Director of Quality Assurance GCP

    Biophase is seeking an experienced Senior Director of GCP Quality Assurance to provide strategic and operational oversight of clinical programs and external partners. This on-site leadership role ensures compliance with ICH GCP and global regulatory requirements while maintaining high standards of data integrity and inspection readiness.

    • Provide GCP oversight to clinical teams, ensuring trials are conducted in accordance with regulatory requirements.
    • Lead risk-based audits (sites, CROs, vendors) for CAPA follow-up.

    Key Responsibilities:

    1. Sustain quality systems through cross-functional partnerships, leading continuous improvement initiatives.
    2. advanced degree preferred).* - *15+ years biopharma QA experience including progressive Clinical QA leadership.*- '´t o u nt bu g 'global reg requiremen ts.< /sp a n >< li > Proven ability assess *compliance risk drive practical solutions* strengthen the team by managing vendor relationships effectively driving results based metrics reporting .

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