QA Commercial Manager
$138–$106,185 year
On-siteSanta Ana, California, United States
EXPIREDSanta Ana, California, United StatesOn-siteFull Time$138–$106,185 yearEnterprise
Full TimeEnterprise
Job Summary
Oversee the QA Support and Audit Management groups by planning functions, coaching personnel, and ensuring timely customer communication. Manage global change notifications for FLBI-PA, LSM, and Toda sites while coordinating internal and external audits, including acting as the customer audit host. Direct supplier qualification, re-evaluation, and performance monitoring programs to maintain compliance with FDA GMPs, ISO 13485, and other regulatory standards. Assist with quality activity coordination across global production sites and serve as the primary voice of the customer for internal inquiries.
Required Qualifications
- BS/BA in Biology, Microbiology, or Chemistry
- Minimum 5 years of QA experience in medical device or biopharmaceutical environment
- Minimum 2 years of People Management experience with direct supervision of a team
- Must be familiar with FDA's GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, Health Canada and MDR requirements
- Excellent computer skills including MS Word, Excel, PowerPoint
- Ability to speak, read, and write proficiently in English
- Good oral and written communication skills
Desired Qualifications
- BS/BA in Biology, Microbiology, or Chemistry preferred
- ISO 13485 or 9001 lead auditor certification preferred
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