Global CDMO Compliance Officer

Fujifilm

Job Location:

Morrisville, NC - USA

Monthly Salary: $ 220000 - 240000

Posted on: 9 days ago

Vacancies: 1 Vacancy

Department:

Regulatory Compliance

Job Summary

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 Biotechnologiesmanage new and evolving compliance risks.

This individual will support the leadership team and will have a dotted line reporting relationship to the FUJIFILM BiotechnologiesCEO.

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.

Company Overview

At FUJIFILM Holdings America Corporation were redefining innovation across the industries we touchfrom healthcare and photography to semiconductors and data storage. With roots in photosensitive materials and a legacy of groundbreaking technology we now lead 23 diverse affiliate businesses across the Americas.

Were looking for mission-driven talents eager to join us to help create market and support a vast portfolio of products. At Fujifilm youll have the opportunity to explore and grow your skills in new exciting ways. Whether youre shaping tomorrows tech or redefining todays processes well provide a flexible work environment and dynamic culture where innovation thrives.

Our Americas HQ is nestled in Valhalla New York a charming town known for its excellent schools beautiful parks and easy access to the vibrancy of New York City.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: Description

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 Corporationenterprise-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 Corporationand Fujifilm policies.
Lead the compliance risk assessment and identify emerging compliance key risk indicators to inform FUJIFILM Holdings Chief Compliance Officer and FUJIFILM BiotechnologiesExecutive 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 Holdingsand 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 HoldingsCompliance and Fujifilm HQs as required and necessary.
Lead develop and mentor the FUJIFILM Biotechnologies and FUJIFILM HoldingsCompliance 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 Holdingsor 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

Bachelors 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:

$220000.00 to $240000.00 depending on experience
Medical Dental Vision
Life Insurance
401k
Paid Time Off

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EEO Information

Fujifilm is committedto 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 ().

Required Experience:

Unclear Seniority

Position OverviewFUJIFILM 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 vac...