Sr. Compliance Analyst

Overview

The Sr. Compliance Analyst is a member of the FUJIFILM Holdings America Corporation Compliance Department and will report to the Regional Life Sciences Compliance Officer (LSCO). The Sr. Compliance Analyst will help conduct day-to-day management of corporate compliance activities (domestic and international) for FUJIFILM Irvine Scientific, Inc. to ensure ongoing corporate compliance with internal and external standards. This is an onsite/hybrid position located in Santa Ana, CA.

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, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services. FUJIFILM Irvine Scientific, Inc. (“FISI”) is a subsidiary of FUJIFILM Holdings America Corporation (“HLUS”) reporting to FUJIFILM Holdings Corporation (“FTYO”).

FUJIFILM Holdings America Corporation is the holding company for North American based FUJIFILM companies operating in many states across the U.S., as well as in Canada, Brazil and Colombia, and engaged in the research, development, manufacture, sale, and service of FUJIFILM products. The company serves a broad spectrum of industries in the U.S., including medical and life sciences, electronic, chemical, graphic arts, information systems, broadcast, and photography.

External US

Responsibilities

• Assist with the development of the U.S. compliance program in line with industry best practices and regulations, and also support the oversight of FUJIFILM Irvine Scientific Inc. international businesses to ensure compliance.
• Conduct compliance policy and procedure assessment, and support development of new or updated polices, procedure or systems to address new risk areas or to improve operations and/or internal controls.
• Conduct compliance risk analyses, identifying potential areas of compliance vulnerability and risk, develop and implement action plans to mitigate potential risks, and follow up on status and effectiveness.
• Manage compliance training program in the areas of Code of Conduct, Antitrust, Anti-Corruption, Data Privacy, and Anti-Money Laundering, among others, to educate employees, including new hires, on legal and ethical standards and to ensure a comprehensive understanding.  Assist in identifying compliance training needs, develop and deliver training to employees to ensure awareness, understanding, and compliance with policies and all rules and regulations.
• Actively support internal auditing and monitoring activities for policy compliance.  Track corrective and preventive action plans associated with previous audit findings and manage internal and external corrective action plans.
• Keep abreast of new legislation and enforcement matters affecting global FUJIFILM Irvine Scientific Inc., operations, as well as industry and compliance best practices.
• Promote reporting of compliance concerns (including use of the compliance reporting systems when appropriate) and generally serve as the FUJIFILM Irvine Scientific Inc. advocate for the establishment of a culture of compliance and sound ethical behavior.
• Collaborate closely with colleagues in Legal, IT, HR, Finance, Quality and Regulatory, and other core functions in order to direct compliance issues through the appropriate channels for investigation and resolution, reporting, and remediation.
• Conduct and oversee time-sensitive, complex investigations of irregularities, fraud, corruption, and/or other violations by analyzing and synthesizing fact patterns, developing and executing testing procedures; reviewing data for patterns and anomalies, conducting electronic reviews of information, developing questions for, conducting, and summarizing interviews with identified parties.
• Develop reports and other materials for FUJIFILM Irvine Scientific Inc. and FUJIFILM Holdings America Corporation management on incidents, emerging compliance challenges, general compliance activities, and communicate the results of investigations, including control deficiencies or weaknesses, fraud matters, root causes, and recommendations, to various stakeholders a