AL Solutions · 3 weeks ago
QA Training Manager
San Diego, CA
Full-time
Onsite
Senior Level
$125K/yr - $150K/yr
7+ years expAL Solutions is a Biologics specialist CDMO seeking an experienced QA Training Manager. The role involves taking ownership of site-wide training and document control programs while leading a dedicated team to ensure cGMP compliance and continuous improvement across the site.
RecruitingStaffing Agency
Hiring Manager
George Higginson
Responsibilities
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
Qualification
Required
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 supporting regulatory inspections and audits
Confident communicator with the ability to work independently and manage multiple priorities
Company
AL Solutions
AL Solutions is a staffing and recruiting industry.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase