FUJIFILM Corporation
QA Commercial Manager
FUJIFILM Corporation, Santa Ana, California, United States, 92725
Overview:
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 companys 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:ResponsibilitiesOversight of QA Support group and Audit management group, including functions, planning, systems, and personnelCoaches, trains and helps personnel within the group to grow and advance in their knowledge and job functionEnsures customer communication is completed fully and in a timely mannerEnsures audits are performed as planned, responded to, and their actions are completed per the agreed upon timeframesReports and tracks department activities to ensure KPIs are metHelps 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 customerManages customer surveys, issues, and questionnaires completionManages supplier questionnaires and qualificationManages audit programManages 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/EducationBS/BA in Biology, Microbiology, or Chemistry preferred3-5 years of QA experience in medical device or biopharmaceutical environmentMust be familiar with FDAs GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, Health Canada and MDR requirementsExcellent computer skills including MS Word, Excel, PowerPointAbility to speak, read, and write proficiently in EnglishGood oral and written communication skillsSalary and Benefits:$81,731- $130,887 depending on experienceMedical, Dental, VisionLife Insurance401kPaid Time OffEEO/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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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 companys 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:ResponsibilitiesOversight of QA Support group and Audit management group, including functions, planning, systems, and personnelCoaches, trains and helps personnel within the group to grow and advance in their knowledge and job functionEnsures customer communication is completed fully and in a timely mannerEnsures audits are performed as planned, responded to, and their actions are completed per the agreed upon timeframesReports and tracks department activities to ensure KPIs are metHelps 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 customerManages customer surveys, issues, and questionnaires completionManages supplier questionnaires and qualificationManages audit programManages 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/EducationBS/BA in Biology, Microbiology, or Chemistry preferred3-5 years of QA experience in medical device or biopharmaceutical environmentMust be familiar with FDAs GMPs (QSR), ISO 13485, MDD 93/42, IVDD 98/79/EC, Health Canada and MDR requirementsExcellent computer skills including MS Word, Excel, PowerPointAbility to speak, read, and write proficiently in EnglishGood oral and written communication skillsSalary and Benefits:$81,731- $130,887 depending on experienceMedical, Dental, VisionLife Insurance401kPaid Time OffEEO/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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