Location
Santa Ana, CA | United States
Job description
We are hiring a Compliance Manager. The Compliance Manager will be responsible for dealing with compliance matters, domestic and international, for FUJIFILM Irvine Scientific, Inc. both independently and as a part of Fujifilm Holdings America Corporation.
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. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation.
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Responsibilities:
- Conduct compliance policy and procedure assessment. Support development of new or updated polices to address new risk areas or to improve operations and/or internal controls.
- Oversee, administer and perform due diligence new and existing third parties (i.e. distributors and their principals, resellers, etc.) and annual compliance certifications.
- Conduct compliance risk analyses. Identify potential areas of compliance vulnerability and risk. Develop and implement action plans to mitigate potential risks.
- Manage compliance training program in the areas of Antitrust, Anti-Corruption, and Anti-Money Laundering, among others, to educate employees on legal and ethical standards and to ensure a comprehensive understanding.
- Administer and oversee FISI import/ export controls, including screening denied party lists, and monitoring sanctions and embargoed countries.
- Execute internal auditing and monitoring for policy compliance.
- Track corrective and preventive action plans associated with previous compliance violations and audit findings.
- Manage internal and external corrective action plans.
- Keep abreast of new legislation and enforcement matters affecting global companies as well as industry and compliance best practices.
- Collaborate closely with colleagues in Legal, Administration IT, HR, Finance, Shared Services, Sales and Marketing, Compliance and Regulatory and other core functions in order to direct compliance issues through the appropriate channels for investigation and resolution, reporting and remediation.
- Prepare management reports to FISI, HLUS and subsidiary management on incidents, investigations, emerging compliance challenges and general compliance activities.
- Conduct pre-acquisition due diligence of new businesses and support integration plan.
- Work with FISI and HLUS to implement new Corporate Compliance policies, administer current policies and respond to annual audit activities.
- Identify areas for Compliance Improvement, develop executive summaries, obtain approvals, implement, train and monitor such improvements Manage the EHS Engineer position, objectives and activities related to EHS.
Experience/ Education:
- BS or BA preferred.
- Biotechnology, pharma or med device industry experience highly preferred.
- Minimum of 3 years of commercial compliance experience for an International Company.
- Experience in the development, initiation, maintenance, and revision of policies and procedures for the general operation of a compliance program and its related activities to prevent illegal, unethical, or improper conduct.
- Experience evaluating and auditing trade compliance matters to identify operational issues and recommend and implement strategies to resolve compliance problems.
- Knowledge of Word, Excel, and PowerPoint.
- Strong project management skills, to include managing and prioritizing multiple concurrent projects, and reporting progress and risks to colleagues and senior management.
- Demonstrated ability to advise and collaborate with management on compliance issues, facilitating risk assessment and developing practical business solutions.
- Knowledge of import/ export regulations including but not limited to:
- OFAC
- National and Internal Import/Export Control Regulations
- ITAR
- DPS checks
- SDN List
- Be aware of and understand foreign sanctions and embargos.
- Knowledge of Environmental, Health and Safety Compliance local, national and internal requirements.
- Ability to speak, read and write English well.
- Good oral and written communication skills, including good grammar skills.
For California, the base salary range for this position is $112,000 to $202,000 annually. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).
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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