QA Commercial Manager

About Us

At FUJIFILM Biosciences, we turn curiosity into breakthroughs that advance the field of life sciences. By offering a comprehensive portfolio of products and services in cell culture media, discovery research reagents, recombinant growth factors and proteins, fine chemicals, and critical assay materials, we partner with the brightest minds in biotech and pharma to tackle the world’s biggest health challenges. Our culture fosters curiosity, collaboration, and innovation, and we pride ourselves on delivering unparalleled quality and service to our partners.

Our headquarters in Santa Ana, California, is surrounded by world-class schools, lush parks, and scenic beaches like Laguna and Huntington, making it an ideal place to live, work, and explore. With additional campuses across the US, Europe, China, and Japan, we offer opportunities to make a difference worldwide.

Responsibilities

• Oversee the QA Support group and Audit Management group, including functions, planning, systems, and personnel.
• Coach, train, and help personnel within the group to grow and advance in their knowledge and job function.
• Ensure customer communication is completed fully and in a timely manner.
• Report and track department activities to ensure KPIs are met.
• Help customers obtain requested information (RFQ, master files, quality questions, investigations, certificates, trending, summaries, follow-up, etc.).
• Act as customer liaison for internal inquiries and provide the voice of the customer.
• Manage customer surveys, issues, and questionnaires completion.
• Manage supplier questionnaires and qualification.
• Manage the global change notification program, including coordination for FLBI-PA, LSM, and Toda sites.
• Manage the audit program, both internal and external (vendor audits); act as customer audit host.
• Ensure audits (both internal and external) are performed as planned, responded to, and their actions are completed per agreed-upon timeframes.
• Manage the supplier management program (including qualification, re-evaluation, material qualification, performance monitoring).
• Assist with coordination of quality activities for Global FLBI production sites, including FLBI-PA, LSM, and Toda.

Requirements

• BS/BA in Biology, Microbiology, or Chemistry preferred.
• Minimum 5 years of QA experience in a medical device or biopharmaceutical environment.
• Minimum 2 years of people management experience with direct supervision of a team.
• Familiarity 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, and PowerPoint.
• ISO 13485 or 9001 lead auditor certification preferred.
• Ability to speak, read, and write proficiently in English with good oral and written communication skills.

Pay

For California, the base salary range for this position is $106,185.25 - $138,230.

Benefits

• Medical, Dental, and Vision insurance.
• Life Insurance.
• 401k.
• Paid Time Off.