QA Commercial Manager
$138–$106,185 year
On-siteSanta Ana, California, United States
Job Summary
Oversee QA Support and Audit Management groups, including functions, planning, systems, and personnel while coaching staff to advance their knowledge. Ensure timely completion of customer communication for change notifications, surveys, and quality incidents, acting as the liaison for internal inquiries and customer audits. Manage supplier qualification, re-evaluation, and the global change notification program across FLBI-PA, LSM, and Toda sites. Track department activities to meet KPIs and coordinate quality activities for global production sites. This role reports directly to the QA Commercial Manager at FUJIFILM Biosciences in Santa Ana, California. The position requires a BS/BA in Biology, Microbiology, or Chemistry with at least five years of QA experience in medical device or biopharmaceutical environments.
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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