Director, Governance, Risk Management & Compliance Operational Auditor

Job Summary

Following the implementation of the Governance, Risk Management, and Compliance (GRC) program and Enterprise Risk Management (ERM) Assessment in the U.S., this new role is being created to continue to develop the U.S. Ethics & Compliance (E&C) operational audit program strategy and optimize our U.S. compliance risk assessments. 

The Director, Governance, Risk Management & Compliance Operational Auditor will oversee and lead the development and execution of the operational audit strategy and report on operational audits of compliance and enterprise risks for Otsuka America Pharmaceutical, Inc. (OAPI) and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), collectively Otsuka.  Additionally, this role will oversee and optimize the U.S. compliance risk assessment processes.  This is a key role to continue to support U.S. E&C's GRC function and the Vice President & U.S. Chief Compliance Officer in executing an effective compliance program.

Job Description

The Director, Governance, Risk Management & Compliance Operational Auditor will be responsible to:

• Develop, implement, and oversee the Otsuka operational audit strategy and program that assess the design and effectiveness of internal controls and identifies potential control gaps that may require remediation for Otsuka’s enterprise and compliance risks.
• Develop and maintain the annual audit plan (and audit universe) through engagement with senior leaders in U.S. E&C and other key Otsuka business stakeholders to ensure it is focused on the highest-risk activities and remains fit-for-purpose.    
• Oversee and lead operational audits of Otsuka’s compliance and enterprise risks, by assessing the design and operating effectiveness of internal controls (through detailed transaction testing) to identify control gaps or risks.
• Oversee, develop, and execute audit process steps, including reviewing audit documentation, designing audit testing procedures, interviewing stakeholders, reviewing and testing controls, and reviewing and documenting testing procedures and observations.
• Validate audit findings and observations with management and communicate final audit results to senior management, through presentations and written reports that address observations, risks, root cause analyses, and recommendations.
• Draft formal written audit reports or other Compliance reports that are clear, concise, and drive meaningful action to strengthen controls and mitigate compliance and enterprise risks.
• Directly manage at least one full time employee (FTE), which includes providing oversight, coaching, ensuring completion of training, and creating and managing team goals.
• Directly manage third party consultants and actively oversee audits and risk assessments conducted by third parties on Otsuka’s behalf, ensuring audit quality and on-time delivery within budget.
• Manage auditing and risk assessment budget, ensuring alignment with financial goals by tracking expenses and identifying cost-saving opportunities.
• Collaborate cross-functionally with other U.S. E&C teams, including Aggregate Spend, Investigations, and Compliance Counsel and internal stakeholders on compliance matters. Establish and maintain effective relationships with internal stakeholders. 
• Draft sections of reports and documents intended for submission to various organizational committees, including the Vice President & U.S. Chief Compliance Officer, OAPI/OPDC Joint Boards of Directors, and Audit Committee.
• Lead and oversee the U.S. Compliance Risk Assessment on an annual basis, working directly with senior management. Develop and recommend risk mitigation and strategies based on risk assessment outcomes.  Ensure the risk assessment process and focus areas are continuously improved to reflect best practices, regulatory trends, and guidelines.
• Support Executive Director, Governance, Risk Management & Compliance and Senior Director, Healthcare Law Auditing & Monitoring with other assignments, as needed.  May include domestic travel up to 25%.
• Maintain a working knowledge of relevant trends, laws and regulations pertaining to healthcare law, regulatory compliance, and auditing.  Assists in developing or improving processes and procedures that promote compliance with healthcare laws, regulations, and guidance.

Qualifications

Required

• At least 10 - 12 years of experience within the pharmaceutical industry performing auditing or monitoring activities and strong understanding of enterprise risk management frameworks, internal controls, and risk assessment and audit methodologies.
• Pharmaceutical, Healthcare, or related industry experience.
• Experience with regulators, external auditors, and independent revi