QA Commercial Manager

Position Description

We are hiring a QA Commercial Manager. The QA Commercial Manager will oversee communication of quality information to external and internal customers. This may include, but is not limited to: change notifications, surveys, qualifications, customer quality incidents, supplier management (qualification and re-evaluation), audits (internal, supplier & customer), and management of customer support related to Quality related questions. This position manages two main groups: QA Support and Audit Management.

Company Overview

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.

Imagine being part of a team that enables life-changing discoveries like new vaccines, therapies, and advancements in regenerative medicine. Our culture fosters curiosity, collaboration, and innovation, and we pride ourselves on delivering unparalleled quality and service to our partners. If you’re ready to make an impact, your future belongs with us at FUJIFILM Biosciences.

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.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

Responsibilities:

• Oversight of QA Support group and Audit management group, including functions, planning, systems, and personnel
• Coaches, trains and helps personnel within the group to grow and advance in their knowledge and job function
• Ensures customer communication is completed fully and in a timely manner
• Reports and tracks department activities to ensure KPI’s are met
• Helps customers obtain requested information (RFQ, master files, quality questions, investigations, certificates, trending, summaries, follow up, etc….)
• Acts as customer liaison for internal inquiries and provide voice of customer
• Manages customer surveys, issues, and questionnaires completion
• Manages supplier questionnaires and qualification
• Manages global change notification program, including coordinator for FLBI-PA, LSM and Toda sites
• Manages audit program, both internal and external (vendor audits); as well as acts as customer audit host
• Ensures audits (both internal and external) are performed as planned, responded to, and their actions are completed per the agreed upon timeframes
• Manages supplier management program (including but not limited to: qualification, re-evaluation, material qualification, performance monitoring)
• Assist with coordination of quality activities for Global FLBI production sites, including but not limited to FLBI-PA, LSM and Toda.
  
  

Required Skills/Education

• BS/BA in Biology, Microbiology, or Chemistry preferred
• 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
• ISO 13485 or 9001 lead auditor certification preferred
• Ability to speak, read, and write proficiently in English.
• Good oral and written communication skills.
  
  

Salary And Benefits

• For California, the base salary range for this position is $106,185.25 - $138, 230. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).
• Medical, Dental, Vision
• Life Insurance
• 401k
• Paid Time Off
  
  

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (flbi@fujifilm.com).