Manager of Tech Investigation at Fujifilm

Position OverviewPosition Description We are hiring a Technical Investigations Manager. The Technical Investigations Manager will oversee collection documentation and management of all customer complaints and inquiries toultimate resolution working cross-functionally with internal teams where needed. They will communicate with customers sales marketing customer service and applicable internal teams and act as a key voice of customer and ensure that customer feedback is fed back into the business. They will also engage and ensure appropriate product compliance in line with SOPs and RA/QA requirements.Company OverviewAt FUJIFILM Irvine Scientific (dba 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 worlds 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 youre ready to make an impact your future belongs with us at FUJIFILM Irvine Scientific (dba 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 70000 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: DescriptionResponsibilities:Manage and mentor Technical Investigators ensuring timely accurate compliant audit-ready and in-budget investigations. This includes providing solutions to customers technical challenges troubleshooting issues and addressing any concerns raised by customersPerform triage assessment of customer cases; determine the nature of direct and indirect customer inquiries and classify them for resolution.Based on competing demands and new information rapidly reprioritize activities as needed.Guide the team in generating and testing hypotheses to determine root causes.Oversee documentation review relevant to cases including legal agreements batch records QC data and commercial and shipping documentation.Utilize the resources within the company such as QA R&D Manufacturing Shipping and Customer Service to identify and confirm root causes.Work collaboratively with internal teams such as Sales FASs R&D and Product Management to offer efficient and effective resolutions to customer inquiries.Maintain compliance of: documentation intake investigations complaint review and approval customer follow-up and communication tracking trending and reporting on program.Ensure complaints are investigated closed within established timeframe.Assess and evaluate training needs of direct reports; ensure training and development needs are met within department plans and budgets.Ensure all corporate and departmental policies and procedures are understood and followed by self and direct reportsEnsure legal and ethical principles and policies are understood and followed by direct reports.Advise management in real time of product technical matters for effective accurate situational awareness and rapid escalation of issues as needed. Foster and maintain the companys reputation as a technical resource and industry leader:Verify that all customer communication is appropriate and professional and demonstrates scientific rigor.Drive continuous improvement within the Technical Investigations team and within the organization to be at the forefront of knowledge and supportCollect customer feedback from complaints and technical interactions and synthesize trendsDefine monitor and have responsibility for meaningful metrics and KPIs track trends and provide management-level reportingFeed insights into New Product Development Product Management and Strategic Marketing Manufacturing Raw Material Specifications and Continuous Improvement ProgramsFrom field customer and internal feedback support Marketing and R&D to generate FAQs and technical notes as a resource for all product lines to support commercial efforts.Develop relevant training to enable widespread adoption of technical information and methodologies for the commercial and support organization.Manage oversee and perform product Compliance activities including but not limited to theAssess when complaint trending should trigger review for CAPA initiation. Provide the necessary data and support to the CAPA owner.Revise or create Complaint Handling & Investigations SOPs based on feedback and data as needed and support cross-function departments on SOP updates for processes that involve the Complaint Handling & Investigations group. Make recommendations for SOP updates based on customer feedback or result of investigations.Ensure all activities comply with applicable regulatory and quality standards (ISO 13485 GMP FDA).Assist in communication with regulatory agencies notified body and competent authorities as associated with Compliance activities.Support customer and regulatory audits.Required Skills/Education: Bachelors Degree in Biology Biochemistry Cell Biology Microbiology Chemistry or related field. Higher level educational degrees (Masters Degree or Ph.D.) are highly desirable and may count towards experience.Five (5) or more years of experience in Technical Support Quality Engineering or Quality/Regulatory Compliance in biotechnology pharmaceutical medical device or related industry.Two (2) or more years of direct supervisory or management experience.GMPs USP ISO Quality Management Systems ISO 9001 and 13485.Familiarity with Quality control methodology including analytical methods such as pH osmolality HPLC and ICP-MS QA control systems and production methodologies.Hands-on mammalian cell culture experience Knowledge of cell culture media biochemistry. Experience can be from education or industry.Ability to obtain cooperation from other groups and lead cross functional teams.Strong critical thinking analytic strategic and creative problem-solving skillset Experience with risk management and Failure Mode Effects Analysis (FMEA).Strong root cause analysis skills required (5-Why fishbone fault-tree etc).Proficient in Microsoft Word Excel PowerPoint Outlook Power BI and Enterprise Resource Planning systems.Leadership people management and decision making.Financial Management.Excellent communication skills in writing and presentingAbility to organize complex information and generate clear concise management-level reports.Ability to speak read and write English proficiently.Additional language skills are preferred.Good oral and written communication skillsSalary and Benefits:For California the base salary range for this position is $103093 - $134204. Compensation for the successful candidate will depend on various factors (e.g. qualifications education prior experience location etc.).Medical Dental VisionLife Insurance401kPaid Time Off*#LI-onsiteEEO InformationFujifilm is committedto 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 InformationIf 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 ().Required Experience:Manager Key Skills Food Safety,Suspicious Activity,Financial Crimes,Administrative Hearings,Ofac,SAR,Public Safety,Law Enforcement,Due Diligence,AML,Criminal History,escalate,Procedures,Subpoenas Employment Type : Unclear Department / Functional Area: Technical Services Experience: years Vacancy: 1 Monthly Salary Salary: 103093 - 134204