QA Commercial Manager at FISI - FUJIFILM Irvine Scientific

FUJIFILM Irvine Scientific, Inc. is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific, Inc. adheres to ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy and expertise in cell culture and compliance provide customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific, Inc. has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.  FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation, reporting to FUJIFILM Holdings Corporation.

We are hiring a Quality Assurance Commercial Manager. The QA Commercial Manager is responsible for overseeing 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.

External US

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
• Ensures audits are performed as planned, responded to, and their actions are completed per the agreed upon timeframes
• 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 audit program
• Manages change notification and supplier management (qualification, re-evaluation, material qualification, performance monitoring)
• Assist with coordination of quality activities for related FISI production sites.

 Required Skills/Education 

• BS/BA in Biology, Microbiology, or Chemistry preferred
• 3-5 years of QA experience in medical device or biopharmaceutical environment
• Minumum of 3 years management or supervisory experience required
• 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

 Salary and Benefits:

• $99,100- $129,100 depending on experience
• Medical, Dental, Vision
• Life Insurance
• 401k
• Paid Time Off

EEO/AGENCY NOTES

Fujifilm is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation, and any other status protected by federal, state, or local law.

To all agencies: Please, no phone calls or emails to any employee of Fujifilm about this requisition. All resumes submitted by search firms/employment agencies to any employee at Fujifilm via-email, the internet or in any form and/or method will be deemed the sole property of Fujifilm, unless such search firms/employment agencies were engaged by Fujifilm for this requisition and a valid agreement with Fujifilm is in place. In the event a candidate who was submitted outside of the Fujifilm agency engagement process is hired, no fee or payment of any kind will be paid.

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