• Vertex Pharmaceuticals (Boston, MA)
    Job Description The Associate Director , Facilities & Engineering Operations Quality Assurance is responsible for providing quality support and oversight for ... a timely manner. This role will report to the Director of Quality Validation and Engineering within the Vertex...robust corrective actions, and risk communication. Serve as Quality Lead or provide support for projects of varied size… more
    Upward (07/01/25)
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  • Associate Director - CSV

    Lilly (Indianapolis, IN)
    …to enable the making of medicine "with safety first and quality always". The CSV Lead will provide technical leadership across the different site and global ... has principal responsibility for supporting all internal and external CSV related audits and privacy related inspections, working in...+ Ability to take initiative, to be assertive, to lead by example and to build high-quality relationships. +… more
    Lilly (07/15/25)
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  • CSV Engineer III

    Fujifilm (College Station, TX)
    …smiles." Visit: https://www.fujifilm.com/us/en/about/region/careers **Job Description** **Reports to** Associate Director , Validation **Work Location** College ... **Position Overview** The Computer System Validation ( CSV ) Engineer III, under general direction, will ...( CSV ) Engineer III, under general direction, will lead the development and approval of validation documentation, risk… more
    Fujifilm (07/04/25)
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  • CSV Manager

    Fujifilm (College Station, TX)
    …smiles." Visit: https://www.fujifilm.com/us/en/about/region/careers **Job Description** **Reports to** Associate Director , Validation **Work Location** College ... **Position Overview** The Manager, CSV will be responsible for management, scheduling, and...day-to-day validation activities.They will provide oversight of validation activities, lead the development and approval of validation documentation, risk… more
    Fujifilm (06/17/25)
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  • Associate Director , GxP Systems

    Vera Therapeutics (Brisbane, CA)
    Title: Job Title: Associate Director , GxP Systems Location: Brisbane, California About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical-stage ... to change the standard of care for patients. Vera's lead product candidate is atacicept, a fully humanized fusion...for patients suffering from immunological diseases. Position Summary: The Associate Director , GxP Systems will report to… more
    Vera Therapeutics (06/25/25)
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  • Senior Scientist Regulatory Compliance

    Cambrex High Point (High Point, NC)
    …submission of CAPA plans, Change Requests, and Deviations in coordination with the Associate Director , Quality Assurance + Author and Revise Quality Documents ... in-process and product specifications and test methods. + Provide feedback and/or lead project and site risk assessments relative to quality management systems and… more
    Cambrex High Point (07/17/25)
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  • Site Automation, Engineer II

    BeOne Medicines (Pennington, NJ)
    …judgment. This role will be based in Hopewell NJ and report to the Associate Director Utilities in Facilities and Engineering. **Essential Functions of the ... PLC and HMI/ SCADA software applications. + Participate and lead in controls fault analysis, root cause analysis and...21CFR Part 11 compliance, and GxP computer systems validation ( CSV ). + Strong experience with one of the following… more
    BeOne Medicines (06/13/25)
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