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Director of Corporate Compliance (HLUS)

FUJIFILM Diosynth Biotechnologies

This is a Contract position in San Francisco, CA posted January 1, 2023.

The work we do at FDB has never been more important—and we are looking for talented candidates to join us.

We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives.

Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe.

We are proud to cultivate a culture that will fuel your passion, energy and drive
– what FDB call Genki.

As we grow our community, our capacity, and capabilities significantly in the next year, we’re looking for passionate people to join our global team.

This is a regional position that will support all US sites ( Texas, North Carolina, Boston and California) as well as contributing to the FDB compliance work globally.

This position is based at either our North Carolina or Texas site (to be on site a minimum of two days a week).

The Director of Corporate Compliance, US will lead the FDB US Corporate Compliance Team reporting to the Senior Director of Corporate Compliance, Global (Senior Director).

The job holder will assist the Senior 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 ”) and FUJIFILM Europe regional headquarters (“ FE RHQ ”).

External US MAJOR ACTIVITIES AND RESPONSIBILITIES: The job holder will be responsible for: 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, Anti-corruption, Anti-trust, Healthcare compliance, Data protection matters (including HIPAA and GDPR compliance), Security trade control matters including iTAR (STC), and Issues relating to government contracting compliance, RINGI and compliance based training/education.

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 Senior Director Number of employees in compliance network as at 1 September: US: 2000 Global: 4000 Note: estimated number due to large number of open ATRs and heavy use of contractors for whom compliance applies and provide support for.

Number will increase Number of staff in Group US: 5 Global: 10 Note: number of staff will grow as the FDB Group grows with an appointment of a CO for any new FDB entity Turnover (FY20): FDB: >$1BN Budget: TBD Forward Work Plan Up to 3 years Note: based on compliance training plan Principal Accountabilities: Implementation and operation of a collaborative Corporate Compliance program (“Compliance Program”): FDB currently operates site specific Compliance Programs largely governed by regional specific policy lead by HLUS and FE RHQ.

FDB wishes to implement a collaborative, FDB wide, Compliance Program that ensures compliance with corporate compliance related regulations; and internal guidelines of FE RHQ; HLUS; and FTYO (“ FDB Compliance Program ”) whilst delivering value to FDB.

The job holder, in collaboration with their European counterpart, will assist the Senior Director to design and implement, a 2 year program during which the existing Compliance Programs will be reviewed and an FDB Compliance Program will be developed and implemented at each of the FDB sites; including a plan for implementation of the FDB Compliance Program at new corporate entities which may join FDB.

The job holder will lead these activities within FDB, US.

During implementation of the FDB Compliance Program the job holder will lead the operation of the existing Compliance Program in FDB, US.

Compliance Program Management: Corporate Compliance: Responsible for the day-to-day management of FDB US’s corporate compliance activities to ensure compliance with (i) laws and regulations, including in the areas of Antitrust, Anti-Corruption, Anti-Money Laundering, Import/Export (specifically including ITAR but not including logistics) 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 HLUS compliance policies.

Responsible for implementing and maintaining good contracting practices in relation to Government contracts entered into by members of the FDB group with US Government bodies.

Conduct policy and procedure assessment.

Support development of new or updated polices to address new risk areas or to improve operations and/or internal controls.

Conduct compliance risk analysis.

Identify potential areas of compliance vulnerability and risk.

Develop and implement heat maps (which will involve reporting on matters of risk relating to areas outside of corporate compliance such as Quality, cGMP Regulation, EHS, HR and Finance) and action plans to mitigate potential risks.

Implement and oversee training programs on areas of compliance including Code of Conduct and in the areas of Antitrust, Anti-Corruption and Bribery, Anti-Money Laundering, Import/Export, and Data Protection & Privacy among others, to educate employees on legal and ethical standards and to ensure a comprehensive understanding.

Assist or lead (as appropriate) audit requests relating to corporate compliance from HLUS, FE RHQ and FTYO.

Execute internal auditing and monitoring for policy compliance.

Track corrective and preventive action plans associated with previous audit findings.

Manage internal and external corrective action plans.

Keep abreast of new compliance matters affecting global companies as well as industry and compliance best practices.

Promote reporting of compliance concerns (including use of the compliance reporting systems when appropriate) and generally serve as the company’s advocate for the establishment of a culture of compliance and sound ethical behavior.

Compliance Officer for an FDB entity Collaborate closely with colleagues in Legal, IT, Finance, EHS, HR and Quality and Regulatory and other core functions in order to direct compliance issues through the appropriate channels for investigation and resolution, reporting and remediation.

Conduct and direct compliance investigations and implement corrective actions with respect to any incidents, complaints or potential non-compliance.

Generate quarterly reports on compliance activities at FDB US for HLUS.

As appropriate, report to FDB’s CEO and HLUS’ Senior Director & Secretary and HLUS’ Chief Compliance Officer on incidents, investigations, emerging compliance challenges and general compliance activities.

Assist with pre-acquisition due diligence of new businesses and develop integration plan in relation to matters of corporate compliance.

Any other duties commensurate with the role.

Data Protection & Privacy: Ensure effectiveness of FDB US’s (i) practices and policies regarding the treatment and handling of personal data (including Protected Health Information), in safeguarding sensitive information and in complying with data protection regulations in relevant jurisdictions, and (ii) data incident response plan.

This will include the maintenance of appropriate policies and procedures.

Implement and maintain FDB US’s GDPR compliance tool.

Monitor and audit compliance with FDB US’s data protection and privacy policies.

Risk Management: Act as Risk Manager.

Implement and manage the FTYO risk management system and reporting requirements across FDB US.

Trade Compliance (Import/Export): Responsible for implementation and management of a security trade control program and policies and associated training including ITAR compliance Provide guidance on all areas of trade compliance (including embargoed and sanctioned country and person reviews) and deemed export/foreign national compliance.

Establishment and management of FDB US Compliance team: Assist in the establishment of a competent cross functional compliance team to enable fulfilment of job holder core accountabilities.

Management of the day to day operation of the FDB US compliance team and external advisors engaged to assist with compliance matters.

Work hand in hand with their counterpart in Europe.

Engagement with and participation in HLUS and FE RHQ compliance programs.

SCOPE MEASURES: The job holder is required to: have a detailed knowledge of the FUJIFILM Diosynth Biotechnologies Group business practices and processes as well and HLUS and FE RHQ compliance programs have an in depth understanding of the biologics industry 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, HLUS teams as well as the proven ability to influence and communicate effectively at all levels have a high working level knowledge of a number of compliance related topics (data protection / STC) a proven track record of successfully delivering change projects be practical and strategic as well as an analytical thinker (desirable) have a good understanding of human factors and its application in investigations travel to support face to face meetings as required BACKGROUND REQUIREMENTS: Competencies: Level: Senior Leader Assessed: Analytical Thinking People Development Achievement & Results Orientation Change Leadership Business Standards & Integrity Relationship Building Degree level qualification required as a minimum: 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: Internal Candidate: External Candidate: Minimum 10yrs managerial experience at FDB Minimum 10yrs experience in a senior level role and with credible experience managing compliance matters Advanced knowledge of at least two of the following topics: data protection, security trade control and risk management and experience in applying these at FDB Qualification in a compliance topic Proven track record of cross functional problem solving / change projects / investigations Proven track record of cross functional problem solving / change projects / investigations Desirable Qualification in LSS to green belt level or equivalent experience / qualification Certified in Healthcare Compliance (CHC) or Certified Compliance; Ethics Professional (CCEP) or Juris Doctor preferred