Compliance Investigation Manager jobs in Santa Ana, CA

Overview

FUJIFILM Irvine Scientific, Inc. (FISI) 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. FISI 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, FISI 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 Manager of Technical Investigations. The Manager of Technical Investigations will be responsible for leading the Technical Investigations Team. They will oversee collection, documentation, and management of all customer complaints and inquiries to ultimate resolution and communication with customers, sales, marketing, customer service and applicable internal teams. The Manager of Technical Investigations will engage and ensure appropriate product compliance in line with SOPs and RA/QA requirements, which includes tasks related to Complaints, CAPA, Quality Planning, and Facility Change Requests (FCRs). They will manage the customer complaint process, including but not limited to, complaint intake, documentation and lead of investigations, customer follow-up and management, tracking, trending and reporting of Complaint Program management and activities. Manage complaint investigations with support from cross-functional teams, and communicate directly with customers. Responsible for CAPA program management and oversight, including but not limited to initiation, assist CAPA owner with investigation, root cause analysis, write-up, implementation of corrections, monitoring for verification and tracking, trending and reporting of CAPA program. Manage company Quality Planning and FCRs from a product compliance perspective.

External US

Responsibilities

• Manage and mentor Technical Service Investigators
• Advise management, in real time, product technical matters for effective, accurate situational awareness and rapid escalation of issues as needed.
• Utilizing the resources within the company and technical investigations team, ensure quick resolution and documentation of customer inquiries. This includes providing timely and accurate solutions to customers' technical challenges, troubleshooting issues, and addressing any concerns raised by customers. Work collaboratively with internal teams, such as customer support, sales, FAS and R&D, to offer efficient and effective resolutions to customer inquiries. Moreover, the company's reputation as a technical resource and industry leader must be maintained, by playing a key role in building and fostering this recognition among customers.
• Manage and drive continuous improvement for metrics for productivity, customer satisfaction and overall customer engagement.
• Revise or create Technical Support SOPs based on feedback and data, as needed.
• Coordinate internal resources and cross-functional teams to implement solutions to product issues or positioning, ensuring that timelines are met and customer satisfaction is achieved.
• Develop relevant training to enable wide spread adoption of technical information and methodologies for commercial and support organization.
• Develop and assist in oversight of key performance indicators (e.g. SCARs, evaluations, etc.) to ensure improvement. Create measurement of indicators to track progress.
• Act as a mentor for direct reports.
• Assess and evaluate training needs of direct reports; ensure training and development needs are met within department plans and budgets. This training requirement may apply to other department personnel.
• Ensure all corporate and departmental policies and procedures are understood and followed by direct reports.
• Ensure legal and ethical principles and policies are understood and followed by direct reports
• Manage, oversee and perform product Compliance activities, including, but not limited to, the following:
• CAPA initiation, closure and investigation support of assigned CAPA owners
• Review and planning for Facility Change Requests (FCR)
• Writing, review and closure of Quality Planning Activities among all sites
• Compliant documentation intake, investigation oversight, complaint review and approval, customer follow-up and communication, tracking, trending and reporting on program
• Determine the nature of direct and indirect customer inquiries, and classify them for resolution.
• Managing and monitoring customer inquiries associated with complaints or CAPAs. Managing and coordinating cross-functional activities for Compliance activities.
• Ensuring timely and accurate closure of customer complaints, CAPAs, FCRs and Quality Planning activities and that established turnaround times are met.
• Ensuring compliance of processes and procedures to applicable standards related to Compliance activities, including but not limited to, complaints, CAPAs, FCRs and Quality Planning.              
• Assisting in the communication with regulatory agencies, notified body, and competent authorities as associated with Compliance activities.

 Required Skills/Education

• Bachelor’s Degree with minimum 5 years of relevant experience in a life sciences space or related industry. Higher level educational degrees (Masters or PhD) are desirable and may count towards experience.
• Five (5) or more years of experience in Technical Support or Customer Service and/or Quality Assurance/Regulatory Affairs/Compliance, technical and customer support in a medical device discipline.
• Two (2) or more years of direct supervisory or management experience.
• GMPs, CFRs, USP, ISO 13485, CMDR, MDD 93/42/EEC, IVD D 98/79/EC, ISO harmonized standards (EN14971, EN 13408, EN 13824).
• Quality control methodology, QA control systems and production methodologies.
• Experience in ART, Cytogenetics, cell and tissue cultures. Experience can be from education or industry.
• Ability to obtain cooperation from other groups and lead cross functional teams.
• Experience with risk management and Failure Mode Effects Analysis (FMEA).
• Strong root cause analysis skills required.
• Proficient in Microsoft Word, Excel, PowerPoint, Outlook.
• Mammalian Cell & Tissue Culture; Biochemistry.

Salary and Benefits:

• For California, the base salary range for this position is $96,666 to $144,900 annually. 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/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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