Global Biotech Compliance Leader - Hybrid NC

FUJIFILM America; Morrisville (NC); Hybrid; USD 220,000 - 270,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life Insurance

401k

Paid Time Off

Job summary

FUJIFILM Holdings America Corporation seeks a Global CDMO Compliance Officer for FUJIFILM Biotechnologies, leading the global compliance team and guiding strategic risk management across the organization.

The role requires 10+ years in compliance within biotech/pharma, with leadership experience in a global, matrixed company; reporting to the Chief Compliance Officer and partnering with Legal and HR.

Qualifications

• Bachelor’s degree. Legal background preferred but not required.
• 10+ years of compliance experience, including 5+ years in the biotechnology or pharmaceutical industry and at least 5 years as Compliance Officer or equivalent senior leadership capacity.
• Experience managing compliance in complex, matrixed, and global organizations.
• Demonstrated knowledge and understanding of the requirements for effective compliance programs as set forth in the OIG Compliance Program Guidance for Pharmaceutical Manufacturers and the U.S. Sentencing Guidelines.

Responsibilities

• Integrate with business functions to gain a deep understanding of the current processes and provide proactive compliance guidance on the development and execution of proposed strategic and tactical initiatives.
• Review business strategy plans and business development opportunities for compliance risks and advise the business on mitigation measures.
• Define and execute the global compliance strategy for FUJIFILM Biotechnologies, aligned with FUJIFILM Holdings America Corporation enterprise-wise compliance framework.
• Consolidate the European and the United States Compliance Programs into one Global Compliance Program.
• Oversee the day-to-day management of FUJIFILM Biotechnologies corporate compliance activities to ensure compliance with laws and regulations and FUJIFILM policies.

Skills

Compliance leadership

Biotech/pharma experience

Regulatory knowledge

Matrix/global organizations

Education

Bachelor’s degree

Job description

FUJIFILM Holdings America Corporation seeks a Global CDMO Compliance Officer for FUJIFILM Biotechnologies, leading the global compliance team and guiding strategic risk management across the organization.

The role requires 10+ years in compliance within biotech/pharma, with leadership experience in a global, matrixed company; reporting to the Chief Compliance Officer and partnering with Legal and HR.