QA Training Manager - San Diego - AL Solutions

    AL Solutions
    AL Solutions San Diego

    13 hours ago

    $75,000 - $115,000 (USD) per year *
    Description

    George Higginson is currently searching for an experienced QA Training Manager with experience across GMP Quality Leadership. Working for a Biologics specialist CDMO, you will take ownership of site-wide training and document control programs, while leading and developing a dedicated team. The role sits at the heart of Quality Operations and plays a key part in ensuring cGMP compliance, inspection readiness, and continuous improvement across the site.

    If you would like to know a bit more about this opportunity, or are considering applying, then please read the following job information.

    The incumbent will operate in a highly cross-functional, stakeholder-facing role, partnering closely with Quality leadership, Manufacturing, Technical Operations, and other functions to ensure the accurate, timely delivery of controlled documentation and training. This is a hands-on leadership position combining people management, system ownership, and day-to-day execution.

    Key responsibilities include:

    • Leading the Document Control and Training functions, including direct people leadership.
    • Owning and enhancing site training and document management programs.
    • Acting as a cGMP champion, ensuring compliance with FDA, EU GMP, and global regulatory requirements.
    • Managing the full lifecycle of GMP documentation (SOPs, batch records, protocols, logbooks, etc.).
    • Driving on-time document workflows and providing Quality metrics.
    • Supporting internal audits, regulatory inspections, and client audits.
    • Maintaining and optimizing electronic document management and training systems.
    • Collaborating cross-functionally to drive consistency and continuous improvement in Quality processes.

    The ideal profile:

    • BS/BA degree, preferably in a scientific discipline.
    • 7+ years of Quality Assurance experience in a GMP-regulated environment.
    • 3-5 years of direct people leadership experience.
    • Strong working knowledge of cGMP, GDP, 21 CFR, EU GMP, and Quality Systems.
    • Experience with Adobe Captivate/Creative.
    • Experience supporting regulatory inspections and audits.
    • Confident communicator with the ability to work independently and manage multiple priorities.

    Ready to take the lead on cutting-edge CMC programs?

    We're looking for someone who thrives in a fast-paced, client-driven environment and is excited to play a pivotal role in delivering life-changing therapies. xhmxlyz If that sounds like you, we'd love to hear from you.

    Apply now or reach out directly for a confidential discussion.

    * This salary range is an estimation made by beBee
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