What are the responsibilities and job description for the QA Training Manager position at AL Solutions?
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:
- 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. If that sounds like you, we’d love to hear from you.
Apply now or reach out directly for a confidential discussion.
Salary : $135,000 - $150,000