Global CDMO Compliance Leader

Position Overview FUJIFILM Holdings America Corporation is seeking an accomplished, talented, and highly motivated individual to serve as Global CDMO Compliance Officer for its FUJIFILM Biotechnologies business, a world-leading contract development and manufacturing organization (CDMO) for biologics, vaccines and advanced therapies. Reporting to the VP, Chief Compliance Officer of FUJIFILM Holdings America Corporation, this individual will serve as the leader of FUJIFILM Biotechnologies global compliance team. The person in this role will have extensive experience in the biotech or pharmaceutical space, will have strong leadership experience and business acumen. The individual will play a critical role in helping FUJIFILM Biotechnologies manage new and evolving compliance risks. This individual will support the leadership team and will have a dotted line reporting relationship to the FUJIFILM Biotechnologies CEO. This is a hybrid position located in North Carolina (Morrisville or Research Triangle Park) With connections across the FUJIFILM Biotechnologies business, as well as FUJIFILM Holdings America Corporation and the wider FUJIFILM group, the Global CDMO Compliance Officer, will be uniquely positioned to spot compliance risks and issues arising in business area and understand their impacts elsewhere to influence and enable senior management to make informed, business-driven decisions. The successful candidate will be expected to direct compliance strategy and help position compliance as a strategic enabler of growth, trust, and long-term value, not a blocker to speed or innovation. 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 (i) laws and regulations, including in the areas of Antitrust, Anti-Corruption, Anti-Money Laundering, Modern Slavery Act and Data Protection & Privacy (but excluding Quality, cGMP Regulation, EHS, HR and Finance) (ii) FUJIFILM corporate policies, including its policies in the above areas as well as the FUJIFILM Code of Conduct and related policies. Develop, enhance, implement and enforce compliance policies and procedures that are fit for FUJIFILM Biotechnologies and reflective of applicable laws, regulations, government guidance, industry codes, FUJIFILM Holdings America Corporation and Fujifilm policies. Lead the compliance risk assessment and identify emerging compliance key risk indicators to inform FUJIFILM Holdings Chief Compliance Officer and FUJIFILM Biotechnologies Executive Leadership. Develop, implement, and provide training on laws, regulations and policies relating to ethics and compliance obligations. Strategize innovative ways to transform internal education initiatives, through acting as a business partner between FUJIFILM Holdings and business functions, to bridge current knowledge gaps with targeted training content. Lead or guide internal investigations into potential compliance violations, ensuring timely resolution, appropriate remediation and consistent disciplinary outcome in collaboration with Legal and HR. Champion a strong culture of compliance and ethical behavior through leadership engagement, communication and awareness initiatives. Partner with HR and Communications to embed compliance into onboarding, performance management, and recognition programs. Establish and execute auditing and monitoring to assess policy adherence and program effectiveness. Ensure robust governance of third-party interactions, promotional practices, and data privacy. Collaborate with Legal to ensure effectiveness of FUJIFILM Biotechnologies (i) practices and policies regarding the treatment and handling of personal data, in safeguarding sensitive information and in complying with data protection regulations in relevant jurisdictions, and (ii) data incident response plan. Continuously assess the effectiveness of the compliance program through data-driven audits, risk assessments, and performance metrics. Keep abreast of legislative and industry codes changes and providing advice/strategic direction in relation to the same. Report material compliance issues and risk to FUJIFILM Holdings Compliance and Fujifilm HQs as required and necessary. Lead, develop and mentor the FUJIFILM Biotechnologies and FUJIFILM Holdings Compliance staff. Serve as a trusted advisor to the executive leadership team, and other functions, providing actionable guidance on compliance matters and risk mitigation. Assist with pre-acquisition due diligence of new businesses and develop integration plan in relation to matters of corporate compliance. Support the local roll out and implementation of projects launched by FUJIFILM Holdings or FH Perform. Liaison with Fujifilm Holdings Information Security team. Any other duties commensurate with the role. Travel internationally as required to support business and compliance objectives. Required Skills / Education 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. Desired Skills Highly advanced interpersonal, relationship-building, and influencing skills are required to support a complex matrix organization. A strategic and analytical thinker, able to influence all levels within the business. Ability to act with autonomy, objectivity, and independence at all times even when under pressure to find solutions to business issues. Excellent verbal and written communicator. Adept at collaborating (business partnering) across divisions, functions, and geography, with a skill for engaging colleagues at all levels in projects and processes while continuing to own and drive them. Self-motivated and able to perform role independently, with a minimum level of supervision. Salary and Benefits $220,000.00 to $240,000.00 depending on experience Medical, Dental, Vision Life Insurance 401k Paid Time Off EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (View email address on click.appcast.io). #J-18808-Ljbffr Merck & Co.