Compliance Investigation Manager oversees investigations of alleged violations of the corporation's ethical standards or non-compliance with applicable laws, regulations and corporate policy. Assigns investigations to professional staff and ensures that staff follows approved investigation procedures. Being a Compliance Investigation Manager ensures that investigations are properly documented and reports findings to authorities as needed. Helps develop compliance training and recommends proactive measures that will reduce the risk of future violations or non-compliance. Additionally, Compliance Investigation Manager requires a bachelor's degree of related area. Typically reports to a head of a unit/department. The Compliance Investigation Manager typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. To be a Compliance Investigation Manager typically requires 3+ years of managerial experience. (Copyright 2024 Salary.com)
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.
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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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