- 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.
- 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.
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QA Training Manager - San Diego - Al Solutions
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.
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:
The ideal profile:
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. If that sounds like you, we'd love to hear from you.
Apply now or reach out directly for a confidential discussion.
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Training Manager
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Manager in Training
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QA Training Manager
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Store Manager in Training
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Store Manager in Training
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Sales Training Manager
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Store Manager in Training
Only for registered members San Diego
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QA Training Manager
Only for registered members San Diego, CA
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Sales Training Manager
Only for registered members San Diego
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Manager in Training - 1675
Only for registered members San Diego, California
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Store Manager in Training
Only for registered members San Diego