Director, Corporate Compliance (HLUS)

Fujifilm Diosynth Biotechnologies (FDB) is a Contract Development and Manufacturing Organization (“CDMO”) with the sole purpose to support our customers as they deliver on the medicines of today and advance the medicines of the tomorrow. In order to provide the required services and support, FDB must first establish mutually beneficial agreements with our customers that detail the assumptions and conditions of the partnership.

External US

Why us:

No matter what role you play in FUJIFILM Diosynth Biotechnologies (“FDB”), you are part of a team that is having a profound impact on the lives of countless individuals and families across the globe.  The manufacturing processes that we develop and the medicines that we produce help protect, improve, extend and save lives. We recognize that in order to maximize our impact and ensure the success of our customers and therefore the success of FDB, we need to build a diverse team of individuals that are driven by a passion that we call “Genki.” 

What is Genki: 

Your Genki is personal, it's your driving force to learn, grow, strive to do better, and strive to be better knowing that your work truly is positively impacting the lives of countless others around the world.

What will you be doing:

As the Director, Corporate Compliance this position is based in the United States and is a regional role that supports all our sites in the United States (North Carolina, Texas, Massachusetts, and California). This role is to be a based from one of our sites in North Carolina or Texas, but has the adaptability to allow remote working for part of the working week.  The position will also require the flexibility to be on site and build internal/external stake holder relationships at the various  US sites.

Job purpose:

The job holder will assist the Global Director with the direction of corporate compliance matters for FDB, both independently and in collaboration with their counterpart(s) in Europe and the compliance teams at FUJIFILM Holdings America Corporation (“HLUS”).

Role Responsibilities:

• Managing, implementing and driving forward regional corporate compliance activities (and the primary contact for HLUS for any corporate compliance based activities) including, but not limited to:
• Investigation management,
• Risk management,
• Compliance based training/education,
• Anti-corruption,
• Anti-trust,
• Healthcare compliance,
• Data protection matters (including HIPAA and GDPR compliance),
• Security trade control matters including ITAR,
• Issues relating to government contracting compliance.
• The job holder will be responsible for influencing HLUS activities for the benefit of FDB and to positively manage the relationship between FDB US and HLUS at all times to maintain trust and collaboration. 
• The job holder will:
• Lead or support (as appropriate) corporate compliance related investigations
• Will build and foster a compliance collaboration across the FDB sites to encourage a One FDB approach to compliance where possible
• Identify and deliver improvements in relation to compliance topics at all levels up to FDB wide
• Provide support to the Global Director

Who you are:

A talented individual with a confident collaborative approach who has a proven compliance and audit experience across a global/international scope. A practical thinker who seeks out the ‘Gemba' way of working…

Job requirements:

• Degree level qualification required or equivalent work experience: being either (i) a qualified lawyer or accountant having experience in compliance matters or (ii) another professional having a background in a Compliance, Audit or Legal Department of an international company. Expert level knowledge of compliance management systems is essential.
• Qualification in LSS to green belt level or equivalent experience/qualification is preferred.
• Certified in Healthcare Compliance (CHC) or Certified Compliance; Ethics Professional (CCEP) or Juris Doctor.
• Understanding of the biologics industry is preferred.
• Act with autonomy; objectivity and independence at all times.
• Possess the interpersonal skills required to deal with multifunctional project teams, external organizations, site and executive leadership teams, regional headquarter teams as well as the proven ability to influence and communicate effectively at all levels.
• Working level knowledge of a number of compliance related topics (data protection / trade compliance / risk management).
• Proven track record in carrying out compliance related investigations.
• Proven track record of successfully delivering change projects.
• Practical and strategic as well as an analytical thinker.
• Good understanding of human factors and its application in investigations is desirable
• Travel to support site face to face meetings as required.

What we offer:

We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package.

As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team.

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company's ability to secure an export authorization.

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please e-mail FDBUHR@fujifilm.com.